'Test and Treat' Among Women at High Risk for HIV-infection in Kampala, Uganda: Antiretroviral Therapy Initiation and Associated Factors.

Data on implementation of 'Test and Treat' among key populations in sub-Saharan Africa are still limited. We examined factors associated with prompt antiretroviral therapy/ART (within 1 month of HIV-positive diagnosis or 1 week if pregnant) among 343 women at high risk for HIV infection in Kampala-Uganda, of whom 28% initiated prompt ART. Most (95%) reported paid sex within 3 months prior to enrolment. Multivariable logistic regression was used to determine baseline characteristics associated with prompt ART. Sex work as main job, younger age and being widowed/separated were associated with lower odds of prompt ART; being enrolled after 12 months of implementing the intervention was associated with higher odds of prompt ART. Younger women, widowed/separated and those reporting sex work as their main job need targeted interventions to start ART promptly after testing. Staff supervision and mentoring may need strengthening during the first year of implementing 'test and treat' interventions

Predictors of lost to follow-up in a "test and treat" programme among adult women with high-risk sexual behavior in Kampala, Uganda.

BACKGROUND: Immediate uptake of antiretroviral therapy (ART) after an HIV-positive diagnosis (Test and Treat) is now being implemented in Uganda. Data are limited on lost to follow-up (LTFU) in high-risk cohorts that have initiated 'Test and Treat'. We describe LTFU in a cohort of women of high-risk sexual behaviour who initiated ART under "Test and Treat". METHODS: We performed a retrospective cohort study of participant records at the Good Health for Women Project (GHWP) clinic, a clinic in Kampala for women at high-risk of HIV-infection. We included HIV positive women ≥18 years who initiated ART at GHWP between August 2014 and March 2018. We defined LTFU as not taking an ART refill for ≥3 months from the last clinic appointment among those not registered as dead or transferred to another clinic. We used the Kaplan-Meier technique to estimate time to LTFU after ART initiation. Predictors of LTFU were assessed using a multivariable Cox proportional hazards model. RESULTS: The mean (±SD) age of the 293 study participants was 30.3 (± 6.5) years, with 274 (94%) reporting paid sex while 38 (13%) had never tested for HIV before enrolment into GHWP. LTFU within the first year of ART initiation was 16% and the incidence of LTFU was estimated at 12.7 per 100 person-years (95%CI 9.90-16.3). In multivariable analysis, participants who reported sex work as their main job at ART initiation (Adjusted Hazards Ratio [aHR] =1.95, 95%CI 1.10-3.45), having baseline WHO clinical stage III or IV (aHR = 2.75, 95% CI 1.30-5.79) were more likely to be LTFU. CONCLUSION: LTFU in this cohort is high. Follow up strategies are required to support women on Test and Treat to remain on treatment, especially those who engage in sex work and those who initiate ART at a later stage of disease

"I prefer to take pills when I plan to have sex": Perceptions of on-demand versus daily oral pre-exposure prophylaxis among adolescents in Kampala, Uganda.

There is limited information about the use of on-demand and daily pre-exposure prophylaxis (PrEP) among adolescents and young people (AYP) in sub-Saharan Africa. We explored perceptions of both regimens among 14- to 19-year-olds perceived to be at high risk of HIV infection in Kampala, Uganda, using qualitative data collection methods. Data were analysed by theme and interpreted based on constructs from the framework of acceptability. Although there were no noticeable gender differences in preferences for a particular regimen, acceptability of PrEP depended on individual AYP sexual behaviour at the time of the study. Those who perceived themselves to be at increased risk of acquiring HIV preferred using daily PrEP, citing the consistency that comes from taking a pill daily and which they considered to be efficacious and safe. AYP who had less frequent sex preferred on-demand PrEP because it would enable them to "plan for sex". However, both groups perceived taking daily PrEP to be a burden, which was an impediment to acceptance of this form of PrEP. AYP anticipated that daily pill taking would be very stressful, requiring a lot of effort and would interrupt their daily routine. Therefore, while both on-demand and daily PrEP were acceptable and beneficial to these AYP, preferences for either regimen depended on self-perceived risk. Thus, oral PrEP use should be tailored to end-user preferences and risk profiles

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

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

Willingness of female sex workers in Kampala, Uganda to participate in future HIV vaccine trials: a case control study.

BACKGROUND: We anticipate large efficacy trials of novel HIV vaccines that have shown acceptable safety profiles. We determined willingness to participate (WTP) in future HIV vaccine efficacy trials among HIV negative female sex workers (FSWs) in Kampala Uganda. METHODS: We conducted a case control study in the Good Health for Women Project cohort. Cases received HIV prevention services and, enrolled in a 12-month simulated vaccine efficacy trial (SiVET) that used Hepatitis B vaccine; they underwent vaccine trial procedures as would be in an actual trial. Controls received similar health services but did not enroll in SiVET. We matched cases and controls (ratio 2:1) for age and duration in the cohort. We described a hypothetical HIV vaccine trial to cases (after 9 months in SiVET) and controls including trial attributes: randomization, delaying pregnancy, frequent blood draws (80-100mls) and study visits for 3 years. We compared WTP and willingness for vaccine trial attributes by case/control using chi-squared or Fisher's exact tests and fitted conditional logistic regression models to determine independent predictors of WTP. RESULTS: We analyzed data for 311 volunteers (219 cases, 92 controls); median age 27 years (IQR: 23-32), 39.9% had ≥secondary education, 57.9% had sex work as their main job and 81.9% used illicit drugs. Compared to controls, more cases had lived in the community for > 1 year, (85.4% vs 64.1%; p < 0.001) and fewer cases reported illicit drug use in the past 3 months, (79.0% vs 89.1%; p = 0.03). Overall, 278 (89.4%) volunteers expressed WTP in an HIV vaccine trial, the most common reason being hope of protection against HIV. More cases than controls (58.2% vs 44.7%) did not need to consult anyone before trial participation (p = 0.03); cases were more willing to delay pregnancy (99.0% vs 94.0%; p = 0.03). Combining vaccine trial attributes, 249 (89.6%) of the 278 accepted all attributes. After controlling for case/ control status women with secondary education or higher expressed less WTP (aOR 0.17; 95% CI 0.04-0.80). CONCLUSION: FSWs in Kampala demonstrated high WTP. Prior experience with trial requirements like contraception may improve their uptake during actual trials. Family involvement is important for those without prior trial experience

High Levels of Persistent Problem Drinking in Women at High Risk for HIV in Kampala, Uganda: A Prospective Cohort Study.

The aim of this study was to describe the epidemiology of problem drinking in a cohort of women at high-risk of HIV in Kampala, Uganda. Overall, 1027 women at high risk of HIV infection were followed from 2008 to 2013. The CAGE and AUDIT questionnaires were used to identify problem drinkers in the cohort. Interviewer-administered questionnaires were used to ascertain socio-demographic and behavioural factors. Blood and genital samples were tested for HIV and other sexually transmitted infections. At enrollment, most women (71%) reported using alcohol at least weekly and about a third reported having drunk alcohol daily for at least 2 weeks during the past 3 months. Over half (56%) were problem drinkers by CAGE at enrollment, and this was independently associated with vulnerability (being divorced/separated/widowed, less education, recruiting clients at bars/clubs, and forced sex at first sexual experience). Factors associated with problem drinking during follow-up included younger age, meeting clients in bars/clubs, number of clients, using drugs and HSV-2 infection. HIV prevalence was associated with drinking at enrollment, but not during follow-up. This longitudinal study found high levels of persistent problem drinking. Further research is needed to adapt and implement alcohol-focused interventions in vulnerable key populations in sub-Saharan Africa

Use of Services among Female Sex Workers Receiving a Comprehensive HIV Enhanced Prevention Intervention in Kampala, Uganda: A Cross-sectional Study.

We estimated the prevalence and factors associated with the use of a dedicated HIV prevention, care, and treatment service for female sex workers (FSWs) in Kampala, Uganda. Between October 2017 to January 2018, we conducted a cross-sectional study among FSWs at a dedicated clinic. We defined use as the use of the HIV prevention, care, and treatment services by FSWs at least once within the past six months. We used the log-binomial model to determine the factors associated with use of clinic services. Eight hundred and seventy-four women were included in the analysis. The overall prevalence of use of clinic services was 81%. At adjusted analysis, use of clinic services was independently associated with being HIV positive and being treated for STIs in the past three months. The prevalence of use of clinic services was high. Dedicated services for FSWs are required to support their use of HIV and STI care

Incidence of unintended pregnancy and associated factors among adolescent girls and young women at risk of HIV infection in Kampala, Uganda.

BACKGROUND: In sub-Saharan Africa, one in every five young women becomes pregnant, and 50% of these are unintended. Pregnancies in adolescent girls and young women (AGYW) are associated with poorer maternal and neonatal outcomes and a high abortion rate, yet data are still limited on incident pregnancies among AGYW in vulnerable situations. We studied the incidence and factors associated with unintended pregnancy among AGYW who were frequently engaged in transactional sex in Kampala, Uganda. METHODS: We analyzed data from a study that investigated the uptake of oral pre-exposure prophylaxis among AGYW from January 2019 to December 2020. Volunteers attended 3-monthly study visits for 12 months each. Contraceptive services were provided to interested volunteers free of charge. Interviewers collected data on sociodemographics, sexual behavior, reproductive health outcomes, and substance use. Pregnancy was determined by testing for beta-human chorionic gonadotropin hormone in urine. The pregnancy incidence rate was estimated using the Kaplan-Meier technique, and logistic regression was used to determine the correlates of pregnancy. RESULTS: We included 285 volunteers with a mean age of 19.9 [standard deviation (SD), ± 2.24] years; 54.7% had attained secondary school education or higher, 57.2% were single (never married), 92.6% reported engaging in transactional sex, 21.0% reported sex work as their main job, 51.9% consumed alcohol in the month prior to the interview, of whom 12.8% consumed alcohol daily, and 25.3% had Chlamydia trachomatis/Neisseria gonorrhoeae. The mean age at first sexual intercourse was 15.7 (SD, ±2.1) years. We recorded 44 pregnancies over 187.2 person-years of follow-up, an incidence of 23.5 per 100 person-years [95% confidence interval (CI), 17.5-31.6]. Incident pregnancies were more likely among volunteers who had ≥10 sexual partners in the past 3 months [adjusted risk ratio (aRR) 1.97; 95% CI, 1.05-3.70] and those who reported not using contraception (aRR 5.89; 95% CI, 2.74-12.66). Incident pregnancies were less likely among those who reported alcohol consumption in the past month (aRR 0.52; 95% CI, 0.30-0.90). CONCLUSION: The incidence of unintended pregnancy was high despite the availability of free contraceptive services. We recommend sociobehavioral studies to explore this further. Sexual and reproductive health campaigns should strengthen demand creation and motivation to use contraception among young women with multiple sexual partners