Retention of adults from fishing communities in an HIV vaccine preparedness study in Masaka, Uganda

Data set containing details of 654 fisherfolk living on the shores of Lake Victoria who were enrolled in an open cohort vaccine preparedness study in Masaka Uganda. They visited the study clinic quarterly to have HIV counselling and testing for a period of two years. At baseline, socio-demographic and HIV risk behaviour data was collected. During follow-up data HIV risk behaviour data was collected every 6 months. Volunteers who did not return for two consecutive visits and those who seroconverted were discontinued from the study

Using observational cohort data from Key populations to plan HIV intervention studies

Background: Globally, new HIV-infections continue to occur mostly in Sub-Saharan Africa despite the known-to-work HIV-prevention interventions. Suboptimal adherence to the available HIV prevention interventions is cited. Vaccination could help minimise non-adherence to an HIV preventive intervention but does require the completion of the full vaccination schedule. An HIV vaccine would be a useful addition to HIV prevention packages, but vaccines need assessment in efficacy trials and investigators need suitable populations for trials. Key populations including Fisher-folks (FF) and Female Sex Workers (FSW) in Uganda could be useful. However, available data for planning trials in these populations come from observational cohorts and evidence suggests that trial environment and/or participants selection could differ from observational cohorts, which could alter trial targeted outcomes. This difference was investigated using Simulated HIV-vaccine efficacy trials (SiVETs); a trial that mimicked an HIV vaccine efficacy trial using a proxy vaccine. Methods: Two SiVETs were nested within observational cohorts of FF (2012 – 2014) and FSW (2014-2017). The SiVETs screened and enrolled participants from observational cohorts, and administered a licensed Hepatitis B vaccine at 0, 1 and 6 months as a proxy for an HIV-vaccine. Over the 12 month follow-up, SiVETs conducted HIV testing, risk behaviour assessment, and promoted and provided reliable contraceptives to women. Results: In total, there were 3989 [1575 FF & 2414 FSW] participants in the observational cohorts and 572 [282 FF & 290 FSW] of these were enrolled into SiVETs. There were significant differences between characteristics of participants in SiVETs and those in the observational cohorts. At 12-months, HIV incidence and risk behaviours were higher in the observational cohorts than SiVETs while retention was lower. Promotion and provision of reliable contraceptives in SiVETs increased the proportion of women using them from 55% at baseline to >90% at the end of vaccination. Conclusion: Researchers designing HIV efficacy trials using observational data in these and similar populations need to consider potential for changes in the targeted trial outcomes following recruitment into trials and its effect on trial statistical power

HIV Combination Prevention study - Data at months 0, 9 and 15

Dataset and supporting documentation collected as part of the HIV combination prevention study, a cluster randomised trial investigating the feasibility of conducting HIV combination prevention interventions in fishing communities in Uganda. The dataset contains participant-provided responses including condom use, HIV prevention practices, and intervention take-up

Feasibility of establishing an HIV vaccine preparedness cohort in a population of the Uganda Police Force: Lessons learnt from a prospective study.

BACKGROUND: Members of uniformed armed forces are considered to be at high risk for HIV infection and have been proposed as suitable candidates for participation in HIV intervention studies. We report on the feasibility of recruitment and follow up of individuals from the community of the Uganda Police Force (UPF) for an HIV vaccine preparedness study. METHODS: HIV-negative volunteers aged 18-49 years, were identified from UPF facilities situated in Kampala and Wakiso districts through community HIV counselling and testing. Potential volunteers were referred to the study clinic for screening, enrolment and quarterly visits for one year. HIV incidence, retention rates were estimated and expressed as cases per 100 person years of observation (PYO). Rate ratios were used to determine factors associated with retention using Poisson regression models. RESULTS: We screened 560 to enroll 500 volunteers between November 2015 and May 2016. One HIV seroconversion occurred among 431 PYO, for an incidence rate of 0.23/100 PYO (95% confidence interval [CI]: 0.03-1.64). Overall, retention rate was 87% at one year, and this was independently associated with residence duration (compared to 5 years aRR = 1.34, 95%CI: 0.95-1.37); absence of genital discharge in the last 3 months (aRR = 1.97, 95% CI: 1.38-2.83, absence of genital ulcers (aRR = 1.90, 95%CI: 1.26-2.87, reporting of new sexual partner in the last month (aRR = 0.57, 95%CI: 0.45-0.71, being away from home for more than two nights (aRR = 1.27, 95%CI: 1.04-1.56, compared to those who had not travelled) and absence of knowledge on HIV prevention (aRR = 2.67, 95%CI: 1.62-4.39). CONCLUSIONS: While our study demonstrates the feasibility of recruiting and retaining individuals from the UPF for HIV research, we did observe lower than anticipated HIV incidence, perhaps because individuals at lower risk of HIV infection may have been the first to come forward to participate or participants followed HIV risk reduction measures. Our findings suggest lessons for recruitment of populations at high risk of HIV infection

Uptake of hormonal contraceptives and correlates of uptake in a phase III clinical trial in rural South Western Uganda.

BACKGROUND: Use of a reliable contraception method has become an inclusion criterion in prevention trials to minimize time off product. We report on hormonal contraceptive prevalence, uptake, sustained use and correlates of use in the Microbicides Development Programme (MDP 301) trial at the Masaka Centre in Uganda. METHODS: HIV negative women in sero-discordant relationships were enrolled and followed-up for 52 to 104 weeks from 2005 to 2009. Contraceptive use data was collected through self-report at baseline and dispensing records during follow-up. Hormonal contraceptives were promoted and provided to women that were not using a reliable method at enrolment. Baseline contraceptive prevalence, uptake and sustained use were calculated. Uptake was defined as a participant who reported not using a reliable method at enrolment and started using a hormonal method at any time after. Logistic regression models were fitted to investigate predictors of hormonal contraceptive uptake. RESULTS: A total of 840 women were enrolled of whom 21 aged ≥50 years and 12 without follow-up data were excluded; leaving 807 (median age 31 IQR 26-38) in this analysis. At baseline, 228 (28%) reported using a reliable contraceptive; 197 hormonal, 28 female-sterilisation, two IUCD and one hysterectomy. As such 579 were not using a reliable contraceptive at enrolment, of whom 296 (51%) subsequently started using a hormonal contraceptive method; 253 DMPA, four oral pills, and two norplant. Overall 193 (98%) existing users and 262 (88%) new users sustained use throughout follow-up. Independent correlates of hormonal contraceptive uptake were: younger women ≤30 years, aOR = 2.5, 95% CI: 1.7-3.6 and reporting not using contraceptives at baseline due to lack of access or money, breastfeeding or other reasons, in comparison to women who reported using unreliable method. CONCLUSION: Promotion and provision of hormonal contraception doubled the proportion of women using a reliable method of contraception. Uptake was pronounced among younger women and those not previously using a reliable method because of lack of access or money, and breastfeeding. Promotion and provision of hormonal contraceptives in trials that require the interruption or discontinuation of investigational products during pregnancy is important to reduce the time off product. TRIAL REGISTRATION: Protocol Number ISRCTN64716212

Comparison of HIV Risk Behaviors Between Clinical Trials and Observational Cohorts in Uganda.

Many key populations have high-risk behaviors for HIV infection making them suitable for HIV vaccine efficacy trials. However, these behaviors may change when participants enroll into a trial. We used HIV simulated vaccine efficacy trials (SiVETs) nested within observational cohorts of fisherfolks and female sex workers in Uganda to evaluate this difference. We screened observational cohort participants for enrolment into SiVETs, until 572 were enrolled. Those not enrolled (n = 953) continued participation in the observational cohorts. We determined risk behaviors at baseline and at 1 year, assigned a numeric score to each behavior and defined composite score as the sum of reported behaviors. We compared changes in scores over 12 months. Both observational cohorts and SiVETs saw a significant decrease in score but greatest in the SiVETs. Investigators recruiting for trials from these populations should consider the likely effect of reduction in risk behaviors on incident HIV infection and trial statistical power

Comparison of retention in observational cohorts and nested simulated HIV vaccine efficacy trials in the key populations in Uganda.

BACKGROUND: Outcomes in observational studies may not best estimate those expected in the HIV vaccine efficacy trials. We compared retention in Simulated HIV Vaccine Efficacy Trials (SiVETs) and observational cohorts drawn from two key populations in Uganda. METHODS: Two SiVETs were nested within two observational cohorts, one in Fisherfolk (FF) and another one in Female Sex Workers (FSW). Adult participants in each observational cohort were screened for enrolment into SiVETs. Those screened-out or not screened continued participation in the observational (non-SiVET) cohorts. SiVET participants were administered a licensed hepatitis B vaccine in a schedule that mimicked an actual HIV vaccine efficacy trial. Both cohorts were followed for 12 months and retention was assessed through dropout, defined as lost to follow up, being uncontactable, refusal to continue or missing the last study clinic visit. Dropout rates were compared using Poisson models giving rate ratios and 95% confidence intervals (95%CI). RESULTS: Out of 1525 participants (565 FF and 960 FSW), 572 (38%) were enrolled into SiVETs (282-FF and 290-FSW), and 953 (62%) remained in the non-SiVET cohorts. Overall, 326 (101 SiVET, 225 non-SiVET) dropped out in 1260 Person Years of Observation (PYO), a dropout rate of 25.9 /100 PYO (95%CI: 23.2-28.8); fewer dropped out in the SiVET cohorts (18.4, 95% CI: 15.1-22.4) than in the non-SiVET cohorts (31.6, 95% CI: 27.8-36.1), rate ratio (RR) =0.58, 95% CI: 0.46-0.73. In all cohorts, the dropout was more marked in FSW than in FF population. Duration lived in community was associated with dropout in both SiVETs and religion in both non-SiVET cohorts. CONCLUSION: The rate of dropout was lower in SiVET compared to non-SiVET cohort. Though the difference in dropout between SiVET and non-SiVET was generally similar, the actual dropout rates were higher in the FSW population. Conduct of SiVETs in these key populations could mean that designing HIV Vaccine Efficacy Trials will benefit from lower dropout rate shown in SiVET than non-SiVET observational cohort

Assessment of quality of care among in-patients with postpartum haemorrhage and severe pre-eclampsia at st. Francis hospital nsambya: a criteria-based audit.

BACKGROUND: The maternal mortality ratio of Uganda is still high and the leading causes of maternal mortality are postpartum haemorrhage (PPH), severe pre-eclampsia and eclampsia. Criteria-based audit (CBA) is a way of improving quality of care that has not been commonly used in low income countries. This study aimed at finding out the quality of care provided to patients with these conditions and to find out if the implementation of recommendations from the audit cycle resulted in improvement in quality of care. METHODS: This study was a CBA following a time series study design. It was done in St. Francis Hospital Nsambya and it involved assessment of adherence to standards of care for PPH, severe pre-eclampsia and eclampsia. An initial audit was done for 3 consecutive months, then findings were presented to health workers and recommendations made; we implemented the recommendations in a subsequent month and this comprised three interventions namely continuing medical education (CME), drills and displaying guidelines; a re-audit was done in the proceeding 3 consecutive months and analysis compared adherence rates of the initial audit with those of the re-audit. RESULTS: Pearson Chi-Square test revealed that the adherence rates of 7 out of 10 standards of care for severe pre-eclampsia/eclampsia were statistically significantly higher in the re-audit than in the initial audit; also, the adherence rates of 3 out of 4 standards of care for PPH were statistically significantly higher in the re-audit than in the initial audit. CONCLUSION: The giving of feedback on quality of care and the implementation of recommendations made during the CBA including CME, drills and displaying guidelines was associated with improvements in the quality of care for patients with PPH, severe pre-eclampsia and eclampsia

Safety of discontinuing cotrimoxazole prophylaxis among HIV infected adults on anti-retroviral therapy in Uganda (COSTOP trial): Design

AbstractIntroductionCotrimoxazole (CTX) prophylaxis is recommended by the World Health Organisation for HIV infected persons. However, once HIV infected patients have commenced ART in resource limited settings, the benefits of continued CTX prophylaxis are not known. The few studies that investigated the safety of discontinuing CTX prophylaxis in these settings had limitations due to their design.Materials and methodsCOSTOP is a randomised double blind placebo controlled non-inferiority trial among HIV infected Ugandan adults stabilised on anti-retroviral treatment (ART). Participants with CD4 count of 250 or more cells/mm3 are randomised to two arms: the intervention arm in which CTX is discontinued and the control arm in which CTX prophylaxis is continued. The study aims to assess whether the intervention regimen is not inferior, with respect to the incidence of pre-defined CTX-preventable events, to the control regimen and superior with respect to the incidence of haematological adverse events.DiscussionStudies that have previously evaluated the safety of discontinuing CTX prophylaxis among HIV infected adults in resource limited settings have provided moderate to low quality evidence owing in part to methodological limitations. COSTOP is designed and conducted with sufficient rigour to answer this question. The results of the trial will assist in guiding policy recommendations.ConclusionThis paper describes the design and methodological considerations important for the conduct of CTX cessation studies