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

Exit interviews administered to patients participating in the COSTOP placebo controlled randomised trial in Uganda.

INTRODUCTION: COSTOP was a randomised controlled trial designed to assess the risks and benefits to HIV-infected participants stabilised on anti-retroviral treatment of stopping cotrimoxazole (CTX). In order to assess the extent to which patients may have had access to and used CTX other than that supplied as study drug it was decided to conduct an exit interview. METHODS: A structured interview was administered by interviewers who were not associated with the COSTOP trial team in order to make it easier for participants to respond truthfully to sensitive questions about adherence to the study protocol. RESULTS: A total of 1993 participants were interviewed. Only 29 (1.7%) said they had taken their left over CTX; 101 (6.1%) had kept supplies at home. When asked about obtaining open label CTX during the trial 92 (4.7%) participants said they had done so, in contrast to only 12 who admitted doing so when asked at trial visits. The questions participants found most difficult to answer honestly at clinic visits were those concerning adherence to trial drugs (15.6% of participants) and whether they had slept under the insecticide treated mosquito nets (14.9%). DISCUSSION: The exit interview demonstrated that there was some evidence of open label drug being taken by the participants. However, the results from the interview do not suggest that the trial results would have been seriously compromised. We would recommend the exit interview as a valuable way of assessing adherence to trial procedures

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

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

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

Prevalence and Factors Associated with Contraceptive Use Among Kenyan Women Aged 15-49 Years.

Uptake of contraceptives is generally low in low-income settings. For women with HIV, contraception is a reliable and affordable method of minimizing vertical transmission. We investigated the factors that affect contraceptive use among Kenyan women using data collected during the Kenya Demographic & Health Survey (KDHS) of 2014. Data on contraceptive use were extracted from the 2014 KDHS database. Records of 31,079 Kenyan women of reproductive age (15-49 years) were analyzed. Frequencies were calculated; cross-tabulations and bivariate and multivariate analyses were conducted. Twelve thousand thirty-two women (39%) reported using a contraceptive method. Region, religion, education, number of living children, marital status, and prior testing for HIV were significantly associated with contraceptive use among women (P < 0.001). Social, economic, and demographic factors predict contraceptive use among Kenyan women and should be addressed in order to increase contraceptive uptake

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

“I fear those things”: non-uptake of contraceptives, and barriers to use among adolescent girls and young women at high risk of HIV infection in Kampala, Uganda

BackgroundAdolescent girls and young women involved in risky behaviors are vulnerable to multiple health problems, yet sexual and reproductive health services remain underutilized. We evaluated factors associated with non-uptake of contraceptives and barriers to use among adolescent girls and young women (14–24 years old) at high risk of HIV infection in an environment where contraceptives were provided at no cost.MethodsWe conducted a mixed methods study, utilizing data from a baseline cross sectional survey and qualitative in-depth interviews. Survey participants tested negative for pregnancy and reported willingness to use contraception. Non-uptake of contraceptives was defined as not taking contraception at any study visit (baseline and throughout the study). Logistic regression model was used to assess factors associated with non-uptake of contraceptives. We purposively selected participants for interviews to discuss their knowledge and experiences with contraceptives and make suggestions to improve uptake. Qualitative data were analyzed thematically.ResultsAll 285 participants were included in the analysis. Out of the 285 participants 127 were not using contraceptives and of the 127, 44 (34.6%) did not take up any method throughout the study while 43 of the 83 remaining participants (who took up a method) chose male condoms only. Non-uptake of contraceptives was less likely among older women (20–24 years) (aOR = 0.32, 95% CI 0.16–0.89) compared to younger women (less than 20 years). Qualitative data showed that concerns about future fertility, fear of associated side effects and influence from close relations contributed to non-uptake of contraception.ConclusionNon-uptake of contraceptives was common despite the promotion and provision of contraceptives in the context of a research study mainly because adolescents lack autonomy while making contraceptive decisions. Identifying and addressing their concerns and continued counselling on contraceptive use alongside condom promotion may improve uptake and utilization of contraceptives

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

Feasibility of conducting HIV combination prevention interventions in fishing communities in Uganda : A pilot cluster randomised trial

Objective We assessed feasibility of an HIV-combination-prevention trial among fishing communities in Uganda. Design Cluster randomised trial in four fishing communities on Lake Victoria, Uganda. Two intervention communities received a combination-prevention-package (behaviour change communication, condom promotion, HIV testing, voluntary male medical circumcision and referral for anti-retroviral therapy if HIV-positive). All four communities received routine government HIV care services. Methods Using household census data we randomly selected a cohort of consenting residents aged 18 years. A baseline sero-survey in July 2014 was followed by two repeat surveys in March and December 2015. We measured uptake of HIV prevention methods, loss-to-follow-up and HIV incidence, accounting for multistage survey design. Results A total of 862 participants were enrolled and followed for 15 months. Participation was 62% and 74% in the control and intervention arms respectively; Overall loss to follow up (LTFU) was 21.6% and was similar by arm. Self-reported abstinence/faithfulness increased between baseline and endline in both arms from 53% to 73% in the control arm, and 55% to 67% in the intervention arm. Reported condom use throughout the study period was 36% in the intervention arm vs 28% in the control arm; number of male participants reporting cir-cumsicion in both arms from 58% to 79% in the intervention arm, and 39% to 46% in the control arm. Independent baseline predictors of loss-to-follow-up were: being HIV positive, residence in the community for 1 month/year Conclusions Recruitment and retention of participants in longitudinal trials in highly mobile HIV fishing communities is challenging. Future research should investigate modes for locating and retaining participants, and delivery of HIV-combination prevention