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Background: Recent studies show that ART is associated with an adverse birth outcome in HIV-infected women. Aim: To compare rates of low birthweight (LBW) and preterm birth (PTB) between HIV-infected women receiving lifelong ART and HIV-uninfected women giving birth in low- and high-risk settings in Malawi. Methods: This observational, registry study was conducted from January 2016 to August 2017 in one large, tertiary referral hospital and four primary healthcare (PHC) facilities in Blantyre, Malawi. Women who delivered singleton live births or stillbirths of ≥20 weeks gestation were included in the analysis. Descriptive and stratified analyses were conducted using χ2 tests and multivariable logistic models to control for maternal age, gravidity and health facility. Results: A total of 14,233 births were included in the analysis (7715 from the tertiary hospital and 6518 from PHC facilities). In the univariable analysis, there were no differences in rates of LBW (6.7% vs 6.4%) and PTB (42.5% vs 42.0%) between HIV-infected and -uninfected women delivering in PHC facilities. However, differences in LBW were significantly higher in HIV-infected women in multivariable analysis (LBW aOR 1.40, 95% CI 1.01–1.95). Rates of LBW and PTB were significantly higher in HIV-infected women than in uninfected women delivering at the tertiary hospital (LBW 17.6% vs 13.2%, aOR 1.53, 95% CI 1.27–1.85; PTB 28.2% vs 24.9%, aOR 1.37, 95% CI 1.17–1.60) Conclusion: Rates of adverse birth outcomes are significantly higher in HIV-infected women than in HIV-uninfected women, and this is more apparent in high-risk hospital settings than in low-risk PHC settings. [ABSTRACT FROM AUTHOR]

Objective: To determine time from delivery to resumption of sexual activity and menses among HIV-infected women on antiretroviral treatment (ART) and HIV-uninfected women.Methods: HIV-infected women on ART and HIV-uninfected women were recruited from five health facilities at delivery and followed prospectively for a maximum of 1 year in Blantyre, Malawi from January 2016 to September 2017. Sociodemographic, clinical, and laboratory data were collected at delivery and 1.5, 3, 6, 9, and 12 months. Descriptive, time to event Kaplan-Meier, and multivariable Cox proportional hazards analyses were conducted.Results: Data on 878 women (460 [52.4%] HIV-uninfected and 418 [47.6%] HIV-infected, P=0.156) who attended at least one follow-up visit were analyzed. Among HIV-uninfected compared to HIV-infected women, respectively, the median number of days to resumption of sexual activity was 180 vs 181; to irregular menses was 82 vs 71; and to regular menses was 245 vs 366. In multivariable models, being married was associated with early resumption of sexual activity (hazard ratio [HR] 1.91, P<0.001), and being HIV-infected and use of an effective method of family planning were associated with later start of regular menses (HR<1.0, P<0.050).Conclusion: Counseling of women on reproductive intentions should start early irrespective of HIV infection or use of ART. [ABSTRACT FROM AUTHOR]

This study aimed to determine changes in fertility intentions of HIV-1 infected and uninfected reproductive age women in Blantyre, Malawi. Participants were asked about their fertility intentions at baseline and at 3-month visits for 1 year. Time-to-event statistical models were used to determine factors associated with changes in fertility intentions. Overall, 842 HIV uninfected and 844 HIV infected women were enrolled. The hazard of changing from wanting no more children at baseline to wanting more children at follow-up was 61% lower among HIV infected women compared to HIV uninfected women ( P < 0.01) after adjusting for other factors, while HIV infected women were ~3 times more likely to change to wanting no more children. The overall pregnancy rate after 12 months was 14.9 per 100 person-years and did not differ among 102 HIV uninfected and 100 infected women who became pregnant. HIV infection is a significant predictor of fertility intentions over time. [ABSTRACT FROM AUTHOR]

Objective: Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV). Design: Randomized, double-masked, placebo-controlled phase 3 trial. Setting: Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi. Participants: Nonpregnant HIV-uninfected and -infected women. Intervention: Intravaginal metronidazole treatment and placebo gels provided at baseline and every 3 mo for 1 y. Outcome measures: Primary: Cross-sectional and longitudinal comparisons of BV frequency at baseline, 1 mo after product dispensation (post-treatment evaluation [PTE]), and every quarterly visit. Secondary: Effect of treatment on BV clearance and recurrence. Results: Baseline: 842 HIV-uninfected and 844 HIV-infected women were enrolled. The frequency of BV at baseline in treatment and placebo arms, respectively, was 45.9% and 46.8% among HIV-uninfected women, and 60.5% and 56.9% among HIV-infected women. Primary outcomes: At the PTEs the prevalence of BV was consistently lower in treatment than placebo arms irrespective of HIV status. The differences were statistically significant mainly in HIV-uninfected women. Prevalence of BV was also reduced over time in both treatment and placebo arms. In a multivariable analysis that controlled for other covariates, the effect of intravaginal metronidazole treatment gel compared with placebo was not substantial: adjusted relative risk (RR) 0.90, 95% confidence interval (CI) 0.83-0.97 in HIV-uninfected women and adjusted RR 0.95, 95% CI 0.89-1.01 in HIV-infected women. Secondary outcomes: Intravaginal metronidazole treatment gel significantly increased BV clearance (adjusted hazard ratio [HR] 1.34, 95% CI 1.07-1.67 among HIV-uninfected women and adjusted HR 1.29, 95% CI 1.06-1.58 among HIV-infected women) but was not associated with decreased BV recurrence. Safety: No serious adverse events were related to use of intravaginal gels. Conclusion: Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV. [ABSTRACT FROM AUTHOR]