High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study.

BACKGROUND: In Uganda, fertility rates and adult HIV prevalence are high, and many women conceive with partners living with HIV. Pre-exposure prophylaxis (PrEP) reduces HIV acquisition for women and, therefore, infants. We developed the Healthy Families-PrEP intervention to support PrEP use as part of HIV prevention during periconception and pregnancy periods. We conducted a longitudinal cohort study to evaluate oral PrEP use among women participating in the intervention. METHODS AND FINDINGS: We enrolled HIV-negative women with plans for pregnancy with a partner living, or thought to be living, with HIV (2017 to 2020) to evaluate PrEP use among women participating in the Healthy Families-PrEP intervention. Quarterly study visits through 9 months included HIV and pregnancy testing and HIV prevention counseling. PrEP was provided in electronic pillboxes, providing the primary adherence measure ("high" adherence when pillbox was opened ≥80% of days). Enrollment questionnaires assessed factors associated with PrEP use. Plasma tenofovir (TFV) and intraerythrocytic TFV-diphosphate (TFV-DP) concentrations were determined quarterly for women who acquired HIV and a randomly selected subset of those who did not; concentrations TFV ≥40 ng/mL and TFV-DP ≥600 fmol/punch were categorized as "high." Women who became pregnant were initially exited from the cohort by design; from March 2019, women with incident pregnancy remained in the study with quarterly follow-up until pregnancy outcome. Primary outcomes included (1) PrEP uptake (proportion who initiated PrEP); and (2) PrEP adherence (proportion of days with pillbox openings during the first 3 months following PrEP initiation). We used univariable and multivariable-adjusted linear regression to evaluate baseline predictors selected based on our conceptual framework of mean adherence over 3 months. We also assessed mean monthly adherence over 9 months of follow-up and during pregnancy. We enrolled 131 women with mean age 28.7 years (95% CI: 27.8 to 29.5). Ninety-seven (74%) reported a partner with HIV and 79 (60%) reported condomless sex. Most women (N = 118; 90%) initiated PrEP. Mean electronic adherence during the 3 months following initiation was 87% (95% CI: 83%, 90%). No covariates were associated with 3-month pill-taking behavior. Concentrations of plasma TFV and TFV-DP were high among 66% and 47%, 56% and 41%, and 45% and 45% at months 3, 6, and 9, respectively. We observed 53 pregnancies among 131 women (1-year cumulative incidence 53% [95% CI: 43%, 62%]) and 1 HIV-seroconversion in a non-pregnant woman. Mean pillcap adherence for PrEP users with pregnancy follow-up (N = 17) was 98% (95% CI: 97%, 99%). Study design limitations include lack of a control group. CONCLUSIONS: Women in Uganda with PrEP indications and planning for pregnancy chose to use PrEP. By electronic pillcap, most were able to sustain high adherence to daily oral PrEP prior to and during pregnancy. Differences in adherence measures highlight challenges with adherence assessment; serial measures of TFV-DP in whole blood suggest 41% to 47% of women took sufficient periconception PrEP to prevent HIV. These data suggest that women planning for and with pregnancy should be prioritized for PrEP implementation, particularly in settings with high fertility rates and generalized HIV epidemics. Future iterations of this work should compare the outcomes to current standard of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03832530 https://clinicaltrials.gov/ct2/show/NCT03832530?term=lynn+matthews&cond=hiv&cntry=UG&draw=2&rank=1.

Pelvic Organ Prolapse and Its Associated Factors Among Women Attending the Gynecology Outpatient Clinic at a Tertiary Hospital in Southwestern Uganda.

Purpose: To determine the prevalence, clinical stage at presentation and factors associated with pelvic organ prolapse (POP) among women attending the gynecology outpatient clinic at Mbarara Regional Referral Hospital (MRRH), Uganda. Methods: We conducted a cross-sectional study at the gynecology outpatient clinic of MRRH from September 2019 to January 2020. Women aged 18-90 years were systematically sampled and recruited into this study. An interviewer administered questionnaire was used to collect participants' socio-demographic, obstetric, gynecological and medical factors. POP stage was obtained by using the pelvic organ prolapse-quantification system. Multivariable logistic regression analysis was done to determine factors associated with pelvic organ prolapse. Results: Of 338 participants enrolled, the prevalence of POP was 27.5% [n = 93, 95% Cl: 23.0-32.5]. POP stages were stage I 11.8% (n = 11), stage II 63.4% (n = 59), stage III 16.1% (n = 15) and stage IV 8.9% (n = 8). Grand-multiparity (aOR 17.1, 95% CI: 1.1-66.6), birth weight more than 3.5kg (aOR 3.7, 95% CI: 1.1-12.6), perineal tears (aOR 6.5, 95% CI: 2.1-20.2), peasant farmer (aOR 6.9, 95% CI: 1.6-29.9) and duration of labour in the first delivery >24 hours (aOR 5.7, 95% CI: 1.2-29) were significantly associated with POP. Conclusion: POP is common among women attending the gynecology clinic at MRRH with most of them presenting with stage II. There should be routine screening for POP to enable early identification and management especially in those who are grand multiparous, peasant farmers and have a history of perineal tears.

Risk factors for recurrence of pelvic organ prolapse after vaginal surgery among Ugandan women: a prospective cohort study.

INTRODUCTION AND HYPOTHESIS: This study was aimed at determining the recurrence rate and risk factors for the recurrence of pelvic organ prolapse (POP), at 1 year post-vaginal reconstructive surgery in a resource-limited setting. METHODS: We enrolled women who underwent vaginal surgery for POP at the urogynecology unit of Mbarara Regional Referral Hospital (MRRH) in southwestern Uganda between December 2018 and February 2020. The surgeries that were performed include anterior colporrhaphy for cystocele, posterior colporrhaphy for rectocele, vaginal hysterectomy with vault suspension for uterine prolapse, and cervicopexy in those with uterine prolapse where uterine-sparing surgery was desired. The women were followed up for a period of 1 year after surgery. Pelvic examinations in lithotomy position under maximum strain were carried out to assess for recurrence using the Pelvic Organ Quantification (POP-Q) system. Recurrence was defined as a prolapse of ≥POP-Q stage II. Descriptive analyses and multivariate log binomial regression were performed to determine risk factors for recurrence. RESULTS: Of the 140 participants enrolled, 127 (90.7%) completed the follow-up at 1 year. The recurrence rate was 25.2% (32 out of 127). Most (56.3%) of the recurrences occurred in the anterior compartment and in the same site previously operated. Women aged <60 years (RR = 2.34; 95% CI: 1.16-4.72; p = 0.018) and those who had postoperative vaginal cuff infection (RR = 2.54; 95% CI: 1.5-4.3; p = 0.001) were at risk of recurrence. CONCLUSION: Recurrence of POP was common. Younger women, and those with postoperative vaginal cuff infection, were more likely to experience recurrent prolapse after vaginal repair.

Impact of surgery on quality of life of Ugandan women with symptomatic pelvic organ prolapse: a prospective cohort study.

BACKGROUND: Pelvic organ prolapse (POP) is a significant public health issue that negatively affects the Quality of Life (QOL) of women in both low and high-income countries. About 20% of women will undergo surgery for POP over their lifetime. However, there is a paucity of information on the effect of surgery on QOL especially in resource-limited settings. We therefore assessed the QOL among women with symptomatic POP living in rural southwestern Uganda and the impact of surgery on their quality of life. METHODS: We conducted a prospective cohort study among 120 women with symptomatic POP scheduled for surgery at the urogynecology unit of Mbarara Regional Referral Hospital. The QOL at baseline and at 1 year after surgery in the domains of physical performance, social interaction, emotional state, sexual life, sleep quality, personal hygiene and urinary bladder function was determined using a King's Quality of Life questionnaire. A paired t-test was used to compare the difference in mean scores at baseline and at 1-year post-surgery. RESULTS: Of the 120 participants that were enrolled at baseline, 117(98%) completed the follow-up period of 1 year. The baseline QOL was poor. The domains with the poorest QOL were physical, social, sexual, emotional and sleep quality. The mean QOL scores in all the domains and the overall QOL significantly improved 1 year after surgery (p < 0.001). The overall QOL improved by 38.9% after surgery (p < 0.001). CONCLUSIONS: The QOL was poor among women with symptomatic POP and surgery improved the QOL in all the domains of life. We recommend that surgery as an option for treatment of symptomatic POP should be scaled up to improve on the QOL of these women.

High HIV-1 prevalence, risk behaviours, and willingness to participate in HIV vaccine trials in fishing communities on Lake Victoria, Uganda.

INTRODUCTION: HIV epidemics in sub-Saharan Africa are generalized, but high-risk subgroups exist within these epidemics. A recent study among fisher-folk communities (FFC) in Uganda showed high HIV prevalence (28.8%) and incidence (4.9/100 person-years). However, those findings may not reflect population-wide HIV rates in FFC since the study population was selected for high-risk behaviour. METHODS: Between September 2011 and March 2013, we conducted a community-based cohort study to determine the population representative HIV rates and willingness to participate (WTP) in hypothetical vaccine trials among FFC, Uganda. At baseline (September 2011-January 2012), a household enumeration census was done in eight fishing communities (one lakeshore and seven islands), after which a random sample of 2200 participants aged 18-49 years was selected from 5360 individuals. Interviewer-administered questionnaire data were collected on HIV risk behaviours and WTP, and venous blood was collected for HIV testing using rapid HIV tests with enzyme-linked immunosorbent assay (EIA) confirmation. Adjusted prevalence proportion ratios (adj.PPRs) of HIV prevalence were determined using log-binomial regression models. RESULTS: Overall baseline HIV prevalence was 26.7% and was higher in women than men (32.6% vs. 20.8%, p<0.0001). Prevalence was lower among fishermen (22.4%) than housewives (32.1%), farmers (33.1%) and bar/lodge/restaurant workers (37%). The adj.PPR of HIV was higher among women than men (adj.PPR =1.50, 95%; 1.20, 1.87) and participants aged 30-39 years (adj.PPR=1.40, 95%; 1.10, 1.79) and 40-49 years (adj.PPR=1.41, 95%; 1.04, 1.92) compared to those aged 18-24 years. Other factors associated with HIV prevalence included low education, previous marriage, polygamous marriage, alcohol and marijuana use before sex. WTP in hypothetical vaccine trials was 89.3% and was higher in men than women (91.2% vs. 87.3%, p=0.004) and among island communities compared to lakeshore ones (90.4% vs. 85.8%, p=0.004). CONCLUSIONS: The HIV prevalence in the general fisher-folk population in Uganda is similar to that observed in the "high-risk" fisher folk. FFC have very high levels of willingness to participate in future HIV vaccine trials.