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Background: Women living with HIV (WLHIV) have lower rates of contraceptive use than noninfected peers, yet concerns regarding contraceptive efficacy and interaction with antiretroviral therapy (ART) complicate counseling. Hormonal contraceptives may increase genital tract HIV viral load (gVL) and sexual transmission risk to male partners. We compared gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation between the levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD) in Cape Town, South Africa. Methods and findings: In this double-masked, randomized controlled noninferiority trial, eligible WLHIV were ages 18–40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART). Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18–23, 24–31, 32–40), and recent injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC. At all visits, participants provided specimens for gVL (primary outcome), pVL, RTI, and pregnancy testing. We assessed gVL and pVL across 6 and 24 months controlling for enrollment measures, ART group, age, and RTI using generalized estimating equation and generalized linear models (non-ART group pVL and hemoglobin) in as-treated analyses. We measured IUC discontinuation rates with Kaplan-Meier estimates and Cox proportional hazards models. We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women. Participant median age was 31 years, and 95% had 1 or more prior pregnancies. Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44–1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68–1.57, p = 0.88). Among ART users, proportions with detectable pVL were not significantly different at 6 (AOR = 0.83, 95% CI 0.37–1.86, p = 0.65) and 24 months (AOR = 0.94, 95% CI 0.49–1.81, p = 0.85), whereas among non-ART women, mean pVL was not significantly different at 6 months (−0.10 log10 copies/mL, 95% CI −0.29 to 0.10, p = 0.50) between LNG-IUS and C-IUD users. IUC continuation was 78% overall; C-IUD users experienced significantly higher expulsion (8% versus 1%, p = 0.02) and elective discontinuation (adjusted hazard ratio: 8.75, 95% CI 3.08–24.8, p < 0.001) rates. Sensitivity analysis adjusted for differential IUC discontinuation found similar gVL results. There were 39 serious adverse events (SAEs); SAEs believed to be directly related to IUC use (n = 7) comprised 3 pelvic inflammatory disease (PID) cases and 4 pregnancies with IUC in place with no discernible trend by IUC arm. Mean hemoglobin change was significantly higher among LNG-IUS users across 6 (0.57 g/dL, 95% CI 0.24–0.90; p < 0.001) and 24 months (0.71 g/dL, 95% CI 0.47–0.95; p < 0.001). Limitations included not achieving non-ART group sample size following change in ART treatment guidelines and truncated 24 months' outcome data, as 17 women were not yet eligible for their 24-month visit at study closure. Also, a change in VL assay during the study may have caused some discrepancy in VL values because of different limits of detection. Conclusions: In this study, we found that the LNG-IUS did not increase gVL or pVL and had low levels of contraceptive failure and associated PID compared with the C-IUD among WLHIV. LNG-IUS users were significantly more likely to continue IUC use and had higher hemoglobin levels over time. The LNG-IUS appears to be a safe contraceptive with regard to HIV disease and may be a highly acceptable option for WLHIV. Trial registration: ClinicalTrials.gov NCT01721798. Catherine Todd and colleagues study an intrauterine contraceptive device in women with HIV infection. Author summary: Why was this study done?: Women living with HIV (WLHIV) infection must consider their contraceptive options in tandem with and complicated by potential interactions between hormonal contraception and HIV disease. These issues potentially contribute to lower use of highly effective hormonal contraceptive methods among WLHIV. Global use of intrauterine contraception (IUC), specifically the levonorgestrel intrauterine system (LNG-IUS), has increased across the last decade. However, there are few trials comparing safety of the LNG-IUS with that of the copper intrauterine device (C-IUD) among WLHIV and none focusing specifically on impact on HIV disease. What did the researchers do and find?: In a randomized controlled trial in Cape Town, South Africa, 199 women with confirmed HIV seropositivity and not desiring pregnancy in the next 30 months were recruited and allocated, with 98 receiving the C-IUD and 101 the LNG-IUS. Participants had genital tract samples collected by menstrual cup and blood taken for genital and plasma viral load levels at enrollment and at 3-, 6-, 12-, 18-, and 24-month visits. Women could return at any time for unscheduled visits and remained in the study even if the IUC was removed on request. Women receiving the LNG-IUS did not have any significant difference in change in detectable genital tract viral load compared with C-IUD users, regardless of ART status. However, women receiving the C-IUD were more likely to have the IUC removed than those receiving the LNG-IUS through the study period. What do these findings mean?: This study is among the first comparing a hormonal to nonhormonal long-acting reversible contraceptive method with genital tract HIV RNA as the primary outcome among WLHIV. These data suggest that LNG-IUS is as safe as the C-IUD for WLHIV and will strengthen international medical eligibility guidelines. The high continuation rates of the LNG-IUS, critically important for a device with a 5-year duration of use, should prompt including this method in the available method mix to promote the ability of WLHIV to meet their fertility goals. [ABSTRACT FROM AUTHOR]

Introduction: Plasma HIV viral load (VL) is the principle determinant of mother-to-child HIV transmission (MTCT), yet there are few data on VL in populations of pregnant women in sub-Saharan Africa.We examined the distribution and determinants of VL in HIV-positive women seeking antenatal care (ANC) in Cape Town, South Africa. Methods: Consecutive HIV-positive pregnant women making their first antenatal clinic visit were recruited into a cross-sectional study of viraemia in pregnancy, including a brief questionnaire and specimens for VL testing and CD4 cell enumeration. Results & discussion: Overall 5551 pregnant women sought ANC during the study period, of whom 1839 (33%) were HIV positive and 1521 (85%) were included. Approximately two-thirds of HIV-positive women in the sample (n=947) were not on antiretrovirals at the time of the first ANC visit, and the remainder (38%, n=574) had initiated antiretroviral therapy (ART) prior to conception. For women not on ART, the median VL was 3.98 log10 copies/mL; in this group, the sensitivity of CD4 cell counts ≤350 cells/μL in detecting VL>10,000 copies/mL was 64% and this increased to 78% with a CD4 threshold of 5500 cells/mL. Among women on ART, 78% had VLB50 copies/mL and 13% had VL >1000 copies/mL at the time of their ANC visit. Conclusions: VL >10,000 copies/mL was commonly observed in women not on ART with CD4 cell counts >350 cells/μL, suggesting that CD4 cell counts may not be adequately sensitive in identifying women at greatest risk of MTCT. A large proportion of women entering ANC initiated ART before conception, and in this group more than 10% had VL>1000 copies/mL despite ART use. VL monitoring during pregnancy may help to identify pregnancies that require additional clinical attention to minimize MTCT risk and improve maternal and child health outcomes. [ABSTRACT FROM AUTHOR]

Background: Women living with HIV (WLHIV) experience high rates of unmet contraceptive need and unintended pregnancy. Contraceptive method-specific continuation rates and associated factors are critical for guiding providers tasked with both reproductive health (RH) and HIV care. We conducted this systematic review to determine whether contraceptive continuation rates differ between WLHIV and uninfected women and, for WLHIV, whether differences are impacted by method type, antiretroviral therapy use or other factors.Methods: We searched Ovid MEDLINE, POPLINE and PubMed.gov for studies published between January 1, 2000, and August 31, 2016. Inclusion criteria comprised prospective data of WLHIV, nonbarrier method continuation as an outcome measure, and recorded method switching and/or discontinuation.Results: Of 939 citations screened, 22 articles from 18 studies were eligible. For studies with comparator groups, data quality was moderate overall based on Grading of Recommendations, Assessment, Development and Evaluations and Newcastle-Ottawa Quality Assessment scales. Of four studies comparing women by HIV serostatus, two showed higher rates of contraceptive continuation among WLHIV versus uninfected women, while two others detected lower continuation rates for the same comparison. Generally, baseline method continuation exceeded 60% for studies with >12months of follow-up. Studies providing contraception had higher continuation rates than studies not providing contraception, while women allocated to contraceptive methods in trials had similar continuation rates to those choosing contraceptive methods. Across all studies, continuation rates differed by method and context, with the copper intrauterine device showing greatest variability between sites (51%-91% continuation rates at ≥12months). Implant continuation rates were ≥86%, though use was low relative to other methods and limited to few studes.Conclusions: Contraceptive continuation among WLHIV differs by method and context. More longitudinal studies with contraceptive continuation as a measured outcome following ≥12months are needed to strengthen integration of RH and HIV care. [ABSTRACT FROM AUTHOR]