Slim disease, characterized by extreme wasting and weight loss, was identified in Rakai district.

ABC program (Abstain, Be faithful, use Condoms) established in Uganda to promote HIV prevention

Document/Source: www.avert.org/hiv-aids-uganda.htm

MOH established this committee to start a health education campaign on the radio, TV, and local press. "Love Carefully" campaign

Population-based cohort study initiated to collect longitudinal data on HIV epidemiology and socioeconomic effects of the epidemic. Started with 21 clusters of 30 households each, (population=1800)

NIH funds HIV Dynamics Study for 3 years; allows Rakai Cohort to expand

Document/Source: Fred Nalugoda, Julia Cummiskey

The capacity of the lab in Kalisizo is limited to to syphilis by RPR with confirmatory TPPA or TPHA. Serum samples frozen and shipped in bulk to UVRI for HIV ELISA testing

Document/Source: Sarah, Margaret - lab

HIV serologic testing by ELISA(Recombigen); positive tests confirmed by Western Blot (Biorad) at UVRI

Document/Source: Berkley et al 1990

Rockefeller Foundation and NIH fund establishment of counseling, health, and education

Document/Source: Fred Nalugoda, Julia Cummiskey

DANIDA and USAID fund establishment of program by Rakai Project. Began as a NGO

Document/Source: Fred Nalugoda, Julia Cummiskey

Funded for 3 yearsNGO

Document/Source: Fred Nalugoda, Julia Cummiskey

Funded for 1 year

Document/Source: Fred Nalugoda, Julia Cummiskey

Mellon foundation funds family planning 1992-1996

Document/Source: Fred Nalugoda, Julia Cummiskey

RF funds 4 year operations reseach on HIV prevention, evaluating health education, risk reduction, condom acceptance & use, HIV testing

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

Under AIDS control program, MOH provides funding to treat STDs.g

Document/Source: Fred Nalugoda

Document/Source: Fred Nalugoda, Julia Cummiskey

Community mapping project that would enable locating communities that would be appropriate to follow for STD Control Trial. Initial study lasted 1 year.

Document/Source: Fred Nalugoda

Range: 21 Feb 1994-17 Dec 1995

Document/Source: Regions and Communities

Baseline, f/u versions created for m, f, transients <6 months (m or f). Questionnaires administered at baseline, 1 year, every year thereafter for 5 years. Functioned as first questionnaire of the Rakai cohort. Assessed demographics, social and sexual behaviors, health status, care seeking, coital frequency. Longest form of cohort questionnaire to be administered

Document/Source: QC team

KASAMBYA picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KYAKKONDA, Kiweesa picked up during A1 (1994-1995)

Document/Source: Regions and Communities

BUYAMBI\KASAALI, Kifukamiza, Kigenya picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KIBIRA, Bijja, Bikira, Gayaza, Kiteredde picked up during A1 (1994-1995)

Document/Source: Regions and Communities

NSAMBYA, Kakoma, Miti, Kirinda picked up during A1 (1994-1995)

Document/Source: Regions and Communities

MITONDO\KYANGO picked up during A1 (1994-1995)

Document/Source: Regions and Communities

MANYAMA, Kalangala, Kamaggwa picked up during A1 (1994-1995)

Document/Source: Regions and Communities

LUSAKA, Vvuma picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KINAAWA, Matale picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KALAGALA, Bulengeza picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KIKUNGWE, Kawuwa picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KYAKAGO/KIBANDA, Bushenyi, Bulanga picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KIBAALE TC. Picked up during A1 (1994-1995)

Document/Source: Regions and Communities

BYAKABANDA, Kageye, Kyandaaza Katerero picked up during A1 (1994-1995)

Document/Source: Regions and Communities

RAKAI TC. Picked up during A1 (1994-1995)

Document/Source: Regions and Communities

BAKIJJULULA, Kamukalo picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KACHANGA, Kyanika, Kakoni Lwabawambya picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KABIRA/KIFUUTA picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KABAWANGA, Kiwumulo, Misoto, Biafra ndeeba picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KAKUUTO, Kitasiba picked up during A1 (1994-1995))

Document/Source: Regions and Communities

KANGABWA, Kalivario picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KABONERA picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KIBAALE/SSANJE, Kannamiti, Mayanja, Katovu picked up during A1 (1994-1995)

Document/Source: Regions and Communities

LWENTULEGE, Kyaluyimuka picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KAAPA KASAMBYA picked up during A1 (1994-1995)

Document/Source: Regions and Communities

NDEEBA\KATOOGO, Kyabigondo, Kayunga, Lwennanga picked up during A1 (1994-1995)

Document/Source: Regions and Communities

LWAMAGGWA picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KACHERA, Kibaati, Katovu, Buyojwa picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KASANKALA picked up during A1 (1994-1995)

Document/Source: Regions and Communities

NIH extended funding for establishment of STD Control Trial for AIDS prevention for 5 years. Provides funding to follow Rakai cohort participants

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

Kalisizo field station increases capabilities to test for more STDs on site in preparation for STD Control Trial. In addition to syphilis, can perform CT/GC, trichimoniasis testing and BV slide reading. Serum samples frozen and shipped in bulk to Entebbe for HIV ELISA testing and further processing

Document/Source: Sarah, Margaret - lab

Two EIA's were run in parallel and discordants run on WB

Document/Source: History of HIV Testing Algorithms

When a person enrolled in the RCCS cohort dies, interviewer to use questionnaire to collect information about recently deceased person from their family members. Limited scope of questions focused on what people are dying from, symptoms at time of death, course of care.

Document/Source: QC team, Fred Nalugoda

Hypothesized that by controlling STIs in the Rakai population, the spread of HIV transmission would be reduceds

Document/Source: RHSP status report Feb 2007

KATANA, Buzirandulu, Nvubu, Kirembwe, Kijej picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KIRUMBA, Kyakalera, Kabasumba, Butembe picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KYAKUDDUSE, Kasambya, Nkenge picked up during A1 (1994-1995)

Document/Source: Regions and Communities

NABIGASA-Kafunda, Ntovu picked up during A1 (1994-1995)

Document/Source: Regions and Communities

NAKATOOGO-East+West, Byerima, Nakasoga picked up during A1 (1994-1995)

Document/Source: Regions and Communities

BETEREMU, Kituntu, Kibonzi, Kasekere, Kasambya picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KITO-NKOKKO, Kasaka, Lutoma picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KICHWAMANGO, Luwama, Kasansula, Kisaana picked up during A1 (1994-1995)

Document/Source: Regions and Communities

BUYAMBA, Kyondo, Kammengo, Nsonso picked up during A1 (1994-1995)

Document/Source: Regions and Communities

DDWANIRO, Katonto, Kireeta Ntimbe Lutub, Nateete Lutilwanjuki picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KISAAYITC picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KIKUNYU, Kareere A+B picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KAGAMBA,Kimuli picked up during A1 (1994-1995)

Document/Source: Regions and Communities

LUTEEBE, Kijjumba, Mpaama, Kikakata, Mukunyu, Kanoni, Kakek picked up during A1 (1994-1995)

Document/Source: Regions and Communities

BUTIITI TC. Picked up during A1 (1994-1995)

Document/Source: Regions and Communities

LWANDA TC. Picked up during A1 (1994-1995)

Document/Source: Regions and Communities

MBUYE, Derinya, Kengobe picked up during A1 (1994-1995)

Document/Source: Regions and Communities

BITABAGO, Lumbugu, Butula, Kirundamaliga, Nsozibbiri, Kikuula picked up during A1 (1994-1995))

Document/Source: Regions and Communities

KIFAMBA, Kagongero, Mmanya, Kitente picked up during A1 (1994-1995)

Document/Source: Regions and Communities

SSANJE, Kabano picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KIGANDA, Lukyamu picked up during A1 (1994-1995)

Document/Source: Regions and Communities

LUTEETE picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KIMUKUNDA, Kalungi, Kisalizi picked up during A1 (1994-1995)

Document/Source: Regions and Communities

MITYEBIRI picked up during A1 (1994-1995)

Document/Source: Regions and Communities

MBIRIZI, Kabala, Kasaasa picked up during A1 (1994-1995)

Document/Source: Regions and Communities

KASASA picked up during A1 (1994-1995))

Document/Source: Regions and Communities

If person deemed eligible for MISS study after RCCS questionnaire, had additional MISS study questionnaire administered, with questions regarding birth and child development. Followed at enrollment, birth, 4 week f/u, every 1 year thereafter.

Document/Source: QC team

Range: 21 Aug 1995-8 Aug 1996/

Document/Source: Regions and Communities

KINAAWA, Matale dropped during A6 (1995-1996)

Document/Source: Regions and Communities

RAKAI HIGH S.S.S picked up during A6 (1995-1996)

Document/Source: Regions and Communities

KITO-NKOKKO, Kasaka, Lutoma dropped during A6 (1995-1996)

Document/Source: Regions and Communities

KAMMENGO TECH.INST. Picked up during A6 (1995-1996)

Document/Source: Regions and Communities

Range: 13 Jun 1996-30 May 1997.

Document/Source: Regions and Communities

RD.WKR KLZ-BIKIRA RD picked up during B1 (1996-1997)

Document/Source: Regions and Communities

RD. WKR SSANJE KIBAALE RD picked up during B1 (1996-1997)

Document/Source: Regions and Communities

Range: 6 Jun 1997 - 8 Oct 1998

Document/Source: Regions and Communities

RD.WKR KLZ-BIKIRA RD dropped during B6 (1997-1998)

Document/Source: Regions and Communities

RD. WKR SSANJE KIBAALE RD dropped during B6 (1997-1998)

Document/Source: Regions and Communities

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

Given poor community knowledge of family planning practices, funding provided resources for intensive education, counseling, and materials for family planning

Document/Source: Fred Nalugoda

Document/Source: www.jhsph.edu/research/centers-and-institutes/rakai-health-sciences-program

Limited ART available in Uganda

Document/Source:

When STD control trial ended, cohort questionnaire was truncated and less people were evaluated. Main clients in follow up were pregnant women who were followed to evaluate effect of STDs on pregnancy, mother, and child

Document/Source: Fred Nalugoda

Use community reproductive health workers to improve family planning uptake through intensive education and counseling

Document/Source: Fred Nalugoda

Infrastructure for adolescent STD care services established for 2 years, and allowed for RCT to evaluate effect of intensive family planning education on adolescents

Document/Source: Fred Nalugoda

Range: 6 Apr 1999 - 14 Feb 2000

Document/Source: Regions and Communities

Infrastructure for adolescent STD care services established for 2 years, and allowed for RCT to evaluate effect of intensive family planning education on adolescents

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

KYOTERA CENTRAL picked up during W1 (1999-2000)

Document/Source: Regions and Communities

KYOTERA LUBIRA picked up during W1 (1999-2000)

Document/Source: Regions and Communities

KIBIRA, Bijja, Bikira, Gayaza, Kiteredde dropped during W1 (1999-2000)

Document/Source: Regions and Communities

KIBAALE TC. Dropped during W1 (1999-2000)

Document/Source: Regions and Communities

RAKAI TC. Dropped during W1 (1999-2000))

Document/Source: Regions and Communities

RAKAI HIGH S.S.S dropped during W1 (1999-2000)

Document/Source: Regions and Communities

KIRUMBA, Kyakalera, Kabasumba, Butembe dropped during W1 (1999-2000)

Document/Source: Regions and Communities

KYAKUDDUSE, Kasambya, Nkenge dropped during W1 (1999-2000)

Document/Source: Regions and Communities

KISAAYITC dropped during W1 (1999-2000)

Document/Source: Regions and Communities

BUTIITI TC. Dropped during W1 (1999-2000)

Document/Source: Regions and Communities

LWANDA TC. Dropped during W1 (1999-2000)

Document/Source: Regions and Communities

NAKATOOKE, Kijonjo picked up during W1 (1999-2000)

Document/Source: Regions and Communities

KIRUULI TC. Picked up during W1 (1999-2000)

Document/Source: Regions and Communities

NTALULE picked up during W1 (1999-2000)

Document/Source: Regions and Communities

LWOYO picked up during W1 (1999-2000)

Document/Source: Regions and Communities

LUGALAMA picked up during W1 (1999-2000)

Document/Source: Regions and Communities

LWENTULEGE, Kyaluyimuka dropped during W1 (1999-2000)

Document/Source: Regions and Communities

KAAPA KASAMBYA dropped during W1 (1999-2000)

Document/Source: Regions and Communities

KACHERA, Kibaati, Katovu, Buyojwa dropped during W1 (1999-2000)

Document/Source: Regions and Communities

LYANTONDE -KALIIRO picked up during W1 (1999-2000)

Document/Source: Regions and Communities

LYANTONDE-KOOKI picked up during W1 (1999-2000)

Document/Source: Regions and Communities

MUKOKOMA picked up during W1 (1999-2000)

Document/Source: Regions and Communities

Grants 3 years of funding (W1-W3), focused on continuing cohort follow-up and exploring community attitude toward HIV vaccine testing (CHER). When cohort participants become seropositive, perform viral epidemiology on HIV subtypes, recombinants, viral set points (MER)

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

Whole blood sent to Entebbe daily via boda for sorting for MER protocol

Document/Source: Sarah, Margaret - lab

CHER questionnaire used at baseline visit modified to includes additional questions about interest in vaccine.

Document/Source: QC team

If subject seroconverts while enrolled in CHER, had additional MER questionnaire administered. Includes more frequent follow up and in depth questions about seroconversion.

Document/Source: QC team

Added questions about receipt of voluntary HIV counseling and testing (VCT)

Document/Source: QC team

Added questions about perceptions, occurrences of domestic violence in home and community

Document/Source: QC team

HIV Molecular Epidemiologic Study (MER) focused on immunological and epidemiological research to better understand how HIV progresses. Specifically focused on post-seroconversion peak viremia, viral set-points, sequencing.

Document/Source: Fred Nalugoda, QC team

Range: 15 Feb 2000 - 19 Feb 2001

Document/Source: Regions and Communities

NIAID provides 5 years funding for Bacterial Vaginosis: Etiology and Sexual Transmission Study to follow natural history of BV in women and study effects of changes in flora on HIV risk

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

KYOTERA CENTRAL dropped during W2 (2000-2001)

Document/Source: Regions and Communities

KYOTERA LUBIRA dropped during W2 (2000-2001)

Document/Source: Regions and Communities

KAMMENGO TECH.INST. Dropped during W2 (2000-2001)

Document/Source: Regions and Communities

NAKATOOKE, Kijonjo dropped during W2 (2000-2001)

Document/Source: Regions and Communities

KIRUULI TC. Picked up during W2 (2000-2001)

Document/Source: Regions and Communities

NTALULE dropped during W2 (2000-2001)

Document/Source: Regions and Communities

LWOYO dropped during W2 (2000-2001)

Document/Source: Regions and Communities

LUGALAMA dropped during W2 (2000-2001)

Document/Source: Regions and Communities

MUKOKOMA dropped during W2 (2000-2001)

Document/Source: Regions and Communities

KYAMUSAALE dropped during W2 (2000-2001)

Document/Source: Regions and Communities

Funded for 2 years

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

Funded for 5 years

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

Funded by NIH as HPTN site for 1 year

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

NCI provides 2 years of funding for the sudy of natural histor of HPV infection and cervical cancer

Document/Source: RHSP Status Report Feb 2007, Fred Nalugoda

Added 1 module for males, females. Focused on gauging interest in family planning, and current contraception use

Document/Source: QC team

Independent short version questionnaire created with questions focused on finding who the opinion leaders were, and who they worked with

Document/Source: QC team

Collected and analyzed data from RCCS on the demographic and social effects of HIV-related reductions in fertility

Document/Source: RHSP Status Report Feb 2007

Multi-center HPTN qualitative study to assess sexual and social networks to determine how to help people uptake services and reduce HIV infections

Document/Source: QC team

Range: 3 Apr 2001 -31 May 2002

Document/Source: Regions and Communities

3 years of funding. RHSP funded to explore ways to reduce pMTCT transmission

Document/Source: RHSP Status Report Feb 2007, Godfrey Kigozi

RCCS questionnaire used at baseline visit, regardless of if person was in cohort, then independent questionnaires with questions about water source, animals in house, genital washing procedures. Administered baseline form, then short f/u form weekly for 1 month, then long f/u form at 1 month and 1 year

Document/Source: QC team

Determine factors associated with high BV prevalence in Rakai in women

Document/Source: Rakai_Report_2010

NVP syringes for mothers and infants provided to HIV+ mothers to administer at home

Document/Source: RHSP status report Feb 2007

sdNVP provided to mothers for pMTCT

Document/Source: Joseph Kagaayi

Range: 15 Jul 2002 - 1 Aug 2003

Document/Source: Regions and Communities

Due to difficulty of obtaining WB kits, Rapids were used as a tie breaker for discordant EIAs in the period of August 2002 and September 2003

Document/Source: History of HIV Testing Algorithms

Funded for 5 years. Assess the safety and STD effects of MC in HIV+ men, effect on their female partners STD risk, and behavioral effects.

Document/Source: RHSP Annual Report 2003-2004, Godfrey Kigozi

Rapid HIV tests were introduced in order to screen subjects for MC trials

Document/Source: Gray et al 2007 Limitations of rapid HIV-1 tests...

NIAID declares RHSP to be part of Uganda's International Center of Excellence in Research (ICER)

Added modules for males to supplement female BV modules also containing questions about water source, animals in house, genital washing procedures

Document/Source: QC team

Find alternative ways of measuring gestation age of newborns - measure heads, chest circumference & weight

Document/Source: Joseph Kagaayi

Assess factors involved in BV in female with multiple partners, or with male partners with multiple female partners

Document/Source: QC team

Analyze self-collected vaginal swabs administered to women followed in RCCS in order to determine prevalence, incidence, and clearance of high-risk HPV infections

Document/Source: Mark-Sklar & Dr. Murokora

Added questions about sexual satisfaction, hygeine to main RCCS questionnaires.

Document/Source: QC team

Range: 26 Sep 2003 - 23 Nov 2004

Document/Source: Regions and Communities

Award provides ongoing laboratory support (equipment, technical assistance, supplies). Permits infrastructure for assessment of HIV viral load, HIV sequencing and transmission linkages, genotyping

Document/Source: Godfrey Kigozi

Doris Duke Charitable Foundation funds construction of new RHSP center in Kalisizo

Document/Source: RHSP Status Report Feb 2007

Over 40 desktop computers and 10 laptops connected to broadband internet via satellite dish at Kalisizo Station

Document/Source: RHSP Annual Report 2003-2004

For MC pilot study, questions about acceptibility, safety, perceptions about MC added into RCCS baseline questionnaire.

Document/Source: QC team

Independent questionnaires created for survey component and qualitative component administered at 2 timepoints to randomly selected subjects in Rakai cohort, with questions focusing on determining what motivates people to participate in studies with or without financial incentive.

Document/Source: QC team

Questions focus on attitude, acceptibility, knowledge of ART

Document/Source: QC team

Determine subject's perceptions on their benefits, risks from study participation

Document/Source: QC team

Key People: Jennifer Wagman, Ezekiel Emanuel

In collaboration with ICER, John Hopkins Malaria Institute funds 1 year study of HIV and malaria co-infection during pregnancy and the effects on MTCT

Document/Source: RHSP Status Report Feb 2007

Social and Ethnographic Research on Networks and Community Opinion Leaders was a downsized version of the original OL study that was better tailored to fit the needs of Rakai district. Facilitation of in depth interviews to help identify popular opinion leaders who could become agents of behavioral change.

Document/Source: RHSP Annual Report 2003-2004

ARV initiation for WHO stage I, II, III in people with CD4<200; ARV initiation for WHO stage IV irrespective of CD4. ART rollout initially funded by World Bank, The Global Fund, and Pepfar

Document/Source: Uganda MOH HIV treatment guidelines

PEPFAR funds the start of ART delivery. Service program provided ART, HCT, CD4 screening, pMTCT, HIV-related care

Document/Source: Gertrude Nakigozi

Mobile Suubi "Hope" clinics that visit communities biweekly and provide HIV care and general health care

Document/Source: Gertrude Nakigozi

1st line: 2 NRTI+1 NNRTI, 2nd line: 2 NRTI+1 PI

Document/Source: Uganda MOH HIV treatment guidelines

RHSP establishes ARV roll out to patients with CD4<250, after site visit to a home-based care program in Tororo. 1st line: 2 NRTI+1 NNRTI, 2nd line: 2 NRTI+1 PI

Document/Source: Gertrude Nakigozi

RCCS questionnaire used for baseline, then for trial participants, short form and long form created. Questions focused on genital washing, acceptibility, sexual satisfaction, info detailing MC procedure. After subjects enrolled at baseline, short forms administered at Day 1, Week 1, weekly thereafter for next 6 weeks in intervention arm. Long form administered at 6 month, 1 year, 2 years in both control and intervention arm

Document/Source: QC team

Allowed RHSP to dispose biological waste in efficient method with minimal environmental pollution

Document/Source: RHSP Annual Report 2003-2004

MC in HIV- men for HIV & STI prevention

Document/Source: Rakai_Report_2010

MC in HIV-, HIV+ men for STI prevention, spousal risk assessment

Document/Source: Rakai_Report_2010

Range: 15 Feb 2005 - 30 Jun 2006

Document/Source: Regions and Communities

New serology laboratory can process: HIV EIA, WB, CrAG, HAV, HBV, HCV, syphilis RPR and TPPA, toxo, ELISPOT

Document/Source: RHSP Status Report 2007

Using Selectra blood chemistry analyzer, new clinical chemistry laboratory can process: serum electrolyte, liver, pancreatic and renal function

Document/Source: RHSP Status Report 2007

New molecular biology laboratory can process: HIV PCR, VL, CT/GC, HPV, CMV, real time PCR, MHA

Document/Source: RHSP Status Report 2007

Assess HIV-1 viral load using Roche Amplicor HIV-1 Monitor Test. Lower limit of detection <400 cpm

Document/Source: Sarah Kalibbala- lab

In addition to new serology, chemistry, molecular bio technology, new lab equipped to process hematology (Coulter), flow cytometry (FACS count), microbiology, mycobacteriology, mycology, parasitology, tissue/cell culture, pathology, media preparation

Document/Source: RHSP status report Feb 2007

Build networks for mutual support, establish violence prevention policies to decrease interpersonal violence and sexual coercion

Document/Source: RCCS-postcirc-share Protocol

Key Person: Jennifer Wagman

Viral load monitoring first became used at RHSP for routine monitoring of all ART clients. Assess virological failure rates in subjects every 3 mon for 1st year after ART initiation, and every 6 months thereafter.

Document/Source: ICER report 2013

BUKUNDA\KABUWOKO picked up during R11 (2005-2005)

Document/Source: Regions and Communities

KITO-NKOKKO, Kasaka, Lutoma picked up during R11 (2005-2005)

Document/Source: Regions and Communities

Funded for 5 years. Provides sufficient resources for maintaining RCCS and continuing to assess questions about effects of ARV rollout on community rates of HIV, morbidity, mortality, fertility, pMTCT, ARV acceptance/adherence, stigma, drug resistant strains

Document/Source: RHSP status report Feb 2007

Funded for 4 years

Document/Source: Fred Nalugoda, Julia Cummiskey

2 years of funding granted, but after unrealistic expectations expressed by funders, RHSP returned grant money

Document/Source: Fred Nalugoda

tx for OI, ctx, bed nets, clean water provided to patients ineligible for ART

Document / Source: Rakai_Report_2010

Independent questionnaire created to assess growth rates, birth rates, questions pertaining to pediatric illnesses

Document / Source: QC team

A continuation of the NVP study, and complementary to MISS study, allowing continued intensive education and access to care. Program starts offering mothers free infant formula, clean vacuum flasks, instructions on use as alternative to breastfeeding.

Document / Source: QC team, Joseph Kagaayi, Fred Nalugoda

A continuation of the NVP study, and complementary to MISS study, allowing continued intensive education and access to care. Program starts offering mothers free infant formula, clean vacuum flasks, instructions on use as alternative to breastfeeding.

Document / Source: Rakai_Report_2010

Study aimed to document trends in HIV, mortality, fertility, and effect on behavior. Funding not alloted for prospective study, so funding returned and study not started.

Document / Source: Fred Nalugoda

Pilot study to assess impact of PHW and warmline staffed by clinicians to improve HIV care. Pilot study ranged May 2006-July 2008

Document / Source: Gertrude, Larry

Assess infectious causes of fever and their effects among clinic participants

Document / Source: www.jhsph.edu/research/centers-and-institutes/rakai-health-sciences-program

BAKKA, BWAMIJJA, NZIRIZI picked up during R12 (2006-2008)

Document / Source: Regions and Communities

Before Rapid tests routinely used for HIV testing for cohort or service clients, started pilot study to evaluate reliability

Document / Source: Fred Nalugoda

Used Binax Now rapid detection test for malaria results at mobile clinics

Document / Source: Sarah Kalibbala- lab

In countries with HIV prevalence rates >3% and generalized heterosexual HIV epidemics, it was recommended that male circumcision become part of the HIV prevention package

Document / Source: http://www.who.int/mediacentre/news/releases/2007/pr10/en/

Assess clinical chemistry and immunochemistry measures by COBAS analyzer series

Document / Source: Sarah, Margaret - lab

CD4/CD8/CD3 evaluated using FACSCalibur. 2 machines available and determination of use is study-specific

Document / Source: Sarah Kalibbala- lab

NIAID provides 5 years of funding to study post trial epidemiological and behavioral surveillance in men enrolled into MC for HIV prevention trial

Document / Source: RHSP Status Report Feb 2007, Godfrey Kigozi

Added questions to assess sexual satisfaction after MC procedure for both males, females.

Document / Source: QC team

Changed questions about ART to ask about acceptibility of ART, knowledge of protection, satisfaction with ART

Document / Source: QC team

Independent enrollment form, f/u form created for males and females focusing on HSV-related questions, examination outcomes, genital cleaning. Administered at baseline, every month thereafter up to 24 months

Document / Source: QC team

Assess long-term effects of MMC, effect on risk behaviors, HIV incidence, and foreskin immunology.

Document / Source: RCCS-postcirc-share Protocol, RHSP status report Feb 2007, Godfrey Kigozi

Measure effect of ART initiation, counseling and risk reduction to serodiscordant couples

Document / Source: Rakai_Report_2010

Assess neurodevelopment in HIV-exposed children

Document / Source: Joseph Kagaayi

RCT of HSV suppression in slowing HIV disease progression in ART-naïve subjects

Document / Source: Rakai_Report_2010

Intensive f/u component of post circ trial to evaluate effect of MMC on PVL, wound healing, safety.

Document / Source: RHSP status report

Range: 6 Jun 2008 - 7 Dec 2009

Document / Source: Regions and Communities

PeerSMART program Bega

Document / Source: Gertrude Nakigozi

Murex test used for HBsAg, ETI test for core Ag

Document / Source: Sarah Kalibbala- lab

BUKUNDA\KABUWOKO dropped during R13 (2008-2009)

Document / Source: Regions and Communities

Assess prevalence of HBV, cirrhosis, and fibrosis in HIV+ and HIV- subjects

Document / Source: Rakai_Report_2010

Started running EIA's in series and stopped testing participants already tested HIV+ twice

Document / Source: History of HIV Testing Algorithms

Murex test used first; if positive result, then sample run on Vironstika Uniform II plus O. Discordant positives run on WB; if sample gives discordant results, then RNA PCR run.

Document / Source: History of HIV Testing Algorithms

Questions about circumcision within RCCS module were reduced because main trials had ended

Document / Source: QC team

Determine effect of hormonal contraception on virological suppression and HIV-disease progression through retrospective analysis

Document / Source: Rakai_Report_2010, Fred Nalugoda

Key Person: Chelsea Polis

Aimed to better understand behavioral aspects of adolescents, connection to their risks for HIV, and how to intervene. Used client-centered care to gauge aspirations of youth and use to create interventional education about risk reduction.

Document / Source: Fred Nalugoda

Range: 18 Jan 2010 - 24 Jun 2011.

Document / Source: Regions and Communities

Assess HIV-1 viral load using Abbott RealTime. Lower limit of detection <50 cpm

Document / Source: Sarah Kalibbala- lab

Began routinely using rapid testing for malaria

Document / Source: Sarah Kalibbala- lab

BAKKA, BWAMIJJA, NZIRIZI dropped during R14 (2010-2011)

Document / Source: Regions and Communities

KITO-NKOKKO, Kasaka, Lutoma dropped during R14 (2010-2011)

Document / Source: Regions and Communities

Resources for HIV counseling and testing mandatory at all hospitals and HC-IV's. Over 2000 healthcare settings facilitate routine or opt-out testing

Document / Source: Global AIDS Response Progress Report; Country Progress Note Uganda; April 2012

Document / Source: Fred Nalugoda

Determine correlates of mucosal protection from HIV infection in high risk, serodiscordant HIV uninfected subjects

Document / Source: Rakai_Report_2010

Study genital bacterial communities and inflammatory markers in HIV+ and HIV- subjects

Document / Source: Rakai_Report_2010

Pregnant mothers with CD4<350 eligible for ARVs. If CD4>350,AZT/3TC starting at 14 weeks gestation, sdNVP at birth+ 7 days AZT/3TC

Document / Source: Joseph Kagaayi

After Armis study concluded, RHSP continued to administer 14 weeks NVP or AZT to infants for pMTCT

Document / Source: Joseph Kagaayi

Integration of services encouraged by PEPFAR. Mobile clinics & home visits eliminated, static RHSP staff placed at select health centers (number of clinicians, nurses based on patient load)

Document / Source: Gertrude Nakigozi

Kasensero and Kibale who had unique populations with high patient loads needing access to ARV services, all other HC-II dropped by RHSP and handed over to MOH

Document / Source: Gertrude Nakigozi

1st line: 2 NRTI+1 NNRTI, 2nd line: 2 NRTI+1 PI

Document / Source: Uganda MOH HIV treatment guidelines

Range: 10 Aug 2011- 5 Jul 2013

Document / Source: Regions and Communities

In order to allow for less frequent ELISA testing, Rapids evaluated with EIA (Murex, then followed by confirmatory Vironostika if +, or Vironosticka or Bio Rad if neg, WB used as final confirmatory test for positives).

Document / Source: Sarah Kalibbala- lab

NEW KYOTER CENTRAL picked up during R15 (2011-2013)

Document / Source: Regions and Communities

BYAKABANDA, Kageye, Kyandaaza Katerero dropped during R15 (2011-2013)

Document / Source: Regions and Communities

BAKIJJULULA, Kamukalo dropped during R15 (2011-2013)

Document / Source: Regions and Communities

NABIGASA-Kafunda, Ntovu dropped during R15 (2011-2013)

Document / Source: Regions and Communities

BETEREMU, Kituntu, Kibonzi, Kasekere, Kasambya dropped during R15 (2011-2013)

Document / Source: Regions and Communities

KATANA, Buzirandulu, Nvubu, Kirembwe, Kijej dropped during R15 (2011-2013)

Document / Source: Regions and Communities

NAKATOOGO-East+West, Byerima, Nakasoga dropped during R15 (2011-2013)

Document / Source: Regions and Communities

KICHWAMANGO, Luwama, Kasansula, Kisaana dropped during R15 (2011-2013)

Document / Source: Regions and Communities

BUYAMBA, Kyondo, Kammengo, Nsonso dropped during R15 (2011-2013)

Document / Source: Regions and Communities

DDWANIRO, Katonto, Kireeta Ntimbe Lutub, Nateete Lutilwanjuki dropped during R15 (2011-2013)

Document / Source: Regions and Communities

KIKUNYU, Kareere A+B dropped during R15 (2011-2013)

Document / Source: Regions and Communities

KAGAMBA,Kimuli dropped during R15 (2011-2013)

Document / Source: Regions and Communities

NDEEBA\KATOOGO, Kyabigondo, Kayunga, Lwennanga dropped during R15 (2011-2013)

Document / Source: Regions and Communities

KASANKALA dropped during R15 (2011-2013)

Document / Source: Regions and Communities

KASENSERO LANDING SITE picked up during R15 (2011-2013)

Document / Source: Regions and Communities

GWANDA, Kinyinga, Lukindu, Misozi, Mirigwe picked up during R15 (2011-2013)

Document / Source: Regions and Communities

KYEBEBalole, Muzzi, Katongero picked up during R15 (2011-2013)

Document / Source: Regions and Communities

DDIMU, picked up during R15 (2011-2013)

Document / Source: Regions and Communities

BBULIRO, picked up during R15 (2011-2013)

Document / Source: Regions and Communities

BUYAGA Nkoma, Bibaale, picked up during R15 (2011-2013)

Document / Source: Regions and Communities

NAMIREMBE picked up during R15 (2011-2013)

Document / Source: Regions and Communities

MUTUKUL TC KOLOLO ZONE picked up during R15 (2011-2013)

Document / Source: Regions and Communities

MUTUKULA CENTRAL picked up during R15 (2011-2013)

Document / Source: Regions and Communities

MOH changed guidelines to use Rapid HIV testing

Document / Source: Fred Nalugoda

Investigated adoption of Alpha questionnaire for verbal autopsies, but found to be too extensive to administer. Truncated version of Alpha questionnaire generated for use with the Rakai cohort

Document / Source: Fred Nalugoda

Independent questionnaires added with questions about signs, symptoms, presence and history of malaria in the home, current preventive practices, diagnostic test of malaria. Questionnaires administered at baseline, every month thereafter until 1 year

Document / Source: QC team

Questions about ARVs reduced because no new information was being captured - education and knowledge of ART was deemed good within community

Document / Source: QC team

Aimed to better characterize effect of HIV and/or ARVs on eyesight. Training implemented in clinics and eye charts set up to evaluate long-term effect of HIV and HIV treatment on vision

Document / Source: Fred Nalugoda

ICER study of epidemiology of malaria in households with children 6 months to 10 years. Administered questionnaires, took blood specimens, and malaria smears for children and primary care givers at baseline, monthly for 1 year. 1600 children enrolled.

Document / Source: Enos Baghendaghe

Facility based observational study of children <5 years presenting with fever at Kalisizo hospital or HC-III. Aimed to improve lab and staff capacity, estimate prevalence of malaria in febrile children, measure treatment outcomes. 3000 children enrolled

Document / Source: Enos Baghendaghe

Study to monitor safety and acceptibility of shangring device as alternative to MMC. 400 men enrolled over 6 months.

Document / Source: Godfrey Kigozi

Range: 8 Jan 2012 - 18 Mar 2013

Document / Source: History of HIV Testing Algorithms

When EIA on the Rapid discordants were found to agree with the Unigold result, testing of discordants was halted.

Document / Source: History of HIV Testing Algorithms

Pima allowed for teams to measure and immediately report CD4 results to patients in the field

Document / Source: Sarah, Margaret - lab

Compare intramuscular vs. subcutaneous Uniject injection of hormonal contraception (depo). Assess acceptibility, administration, ease of use for client and provider, effectiveness.

Document / Source: Gertrude Nakigozi

In addition to monitoring effect of MC on HIV incidence, train midwives to perform early infant circumcisicion, and perform on 500 infants

Document / Source: Godfrey Kigozi

Assess effect of MC on HIV incidence by monitoring cohorts. Evaluate effect of early infant MC on HIV trends/care

Document / Source: Godfrey Kigozi

Adjustment was made in that both Vironostika (Uniform) and Biorad could be used as the 2nd or 3rd EIA depending on availability. Bio Rad better utilized as 2nd EIA since kits were larger, more cost effective.

Document / Source: History of HIV Testing Algorithms

Pregnant mothers eligible for ARVs regardless of CD4 count or clinical staging

Document / Source: Joseph Kagaayi

Funded for 5 years. Enables follow up of RCCS

Document / Source: Godfrey Kigozi, Fred Nalugoda

Free cataract surgery provided at 3 mobile clinics

Document / Source: Gertrude, Fred

Due to decreases in PEPFAR funding, reagents for clinical chemistry not purchased as routinely and panels run less frequently

Document / Source: Sarah Kalibbala- lab

All RHSP health centers and central processing equipped to use OpenMRS to maintain electronic patient HIV care records

Document / Source: Anthony Ndayanabo

Added sexual partner mobility tool to RCCS cohort to track movement of sexual partners associated with fishing communities

Document / Source: QC team

Measure high risk HPV in HIV+ women before and after ART

Document / Source: ICER report 2013

5 year study to monitor demographics, reproductive health services, HIV education of Rakai district. Retrospective quantitative component and prospective qualitative component to analyze risk behaviors for HIV acquisition.

Document / Source: Tom Lutalo, Fred Nalugoda

Qualitative study to find out why men do not seek care (especially with regards to HIV care)

Document / Source: Godfrey Kigozi

Study to monitor safety and acceptibility of prepex device as alternative to MMC. 350 men enrolled over 6 months.

Document / Source: Godfrey Kigozi

Pregnant mothers with CD4<350 eligible for ARVs. If CD4>350, AZT/3TC starting at 14 weeks gestation, sdNVP at birth+ AZT/3TC until breastfeeding cessation

Document / Source: Joseph Kagaayi

MOH changed guidelines to administer 6 weeks of ARVs (AZT or NVP) to infants for pMTCT

Document / Source: Joseph Kagaayi

Range: 7 Jan 2013 - still on

Document / Source: Regions and Communities

No third EIA performed. Two EIA will follow the rapids and any discordant will go for RNA PCR.

Document / Source: History of HIV Testing Algorithms

During R16, surveyors performed CD4 monitoring by Pima to supplement HIV testing during round survey

Document / Source: Sarah, Margaret - lab

Mulembe Mambe campaign initiated to destigmatize MC in older populations

Document / Source: Veena Billoux

Encouraged by PEPFAR, RHSP evaluates district's readiness to takeover health centers, trains MOH workers, and starts to transfer health centers to district.

Document / Source: Gertrude Nakigozi

Since MOH maintained status of health centers at Kasensero and Kibale as HC-II, RHSP keeps staff stationed at sites in order to administer much needed ARV care delivery

Document / Source: Gertrude Nakigozi

3 year study to test for malaria antibodies to see if possible to produce malaria vaccine for pregnant women. Target N=1100 mothers to be enrolled at maternity ward and antenatal clinic

Document / Source: Enos Baghendaghe

Parallel Rapid HIV testing maintained for cohort clients, but lab switched to serial Rapid testing for service clients

Document / Source: History of HIV Testing Algorithms

Measure and compare moisture levels in different penile regions in circumcised and uncircumcised men

Document / Source: Godfrey Kigozi

Retrospective analysis of mortality trends funded

Document / Source: Godfrey Kigozi

4 year training grant funded

Document / Source: Godfrey Kigozi

Liver study protocol dictated use of Monolisa test for HBV

Document / Source: Sarah, Margaret - lab

Independent questionnaire created. Only administered once to each participant: focused on questions about pregnancy, prophylaxis, indications for malaria, current complaints

Document / Source: QC team

Examine the etiology of accelerated liver disease in HIV+ subjects

Document / Source: ICER report 2013

Assess CNS events in 3 groups: ART naïve CD4<200, ART suppressed, HIV negative

Document / Source: QC team

Study to monitor safety and acceptibility of shangring device as alternative to MMC. 350 adolescent men enrolled over 6 months.

Document / Source: Godfrey Kigozi

Range: 2013 - 2013

Document / Source: Regions and Communities

Range: 2013 - still on

Document / Source: Regions and Communities

Assessed 50 men at intake visit to test device to measure penile circumference for potential used during MMC. Study spanned only 2 weeks.

Document / Source: Godfrey Kigozi

1st line: 2 NRTI+1 NNRTI (pref TDF/3TC/EFV). Secondary: AZT/3TC/EFV, AZT/3TC/NVP, TDF/3TC/NVP. 2nd line: 2 NRTI+1 boosted PI

Document / Source: Uganda MOH HIV treatment guidelines

CDC funds roll-out of Prepex to community. 400 people over 3-4 months

Document / Source: Godfrey Kigozi

Compare moisture levels on outer foreskin, inner foreskin, and glands in both circumcised (MMC) and uncircumcised men

Document / Source: Godfrey Kigozi

Kibale, Kasensero and 4 other HC-II with high risk communities upgraded to HC-IIIs by MOH

Document / Source: Fred Nalugoda

World Bank provides funding for cross sectional evaluation of comination HIV prevention.

Document / Source: Godfrey Kigozi