Pregnancy Incidence and Risk Factors among Women Participating in Vaginal Microbicide Trials for HIV Prevention: Systematic Review and Meta-Analysis

Musekiwa, Alfred; Muchiri, Evans; Manda, Samuel; Mwambi, Henry

doi:10.1371/journal.pone.0077014

Cited by 9 publications

(9 citation statements)

References 25 publications

(38 reference statements)

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“…Despite counseling and provision of highly effective contraceptive methods during HIV prevention trials, pregnancies occurred among 6–27% of participants while under study. 5 In many trials, study product use was stopped once pregnancy was diagnosed; therefore, exposure to the investigational products is limited to early pregnancy. Because pregnant women are also an important target population for effective HIV prevention interventions, several phase I and II trials have been implemented to evaluate the safety of ARV-based HIV prevention in pregnancy at later gestational ages.…”

Section: Introductionmentioning

confidence: 99%

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials

Mhlanga

Noguchi

Balkus

et al. 2017

HIV Clinical Trials

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Background Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. Methods The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. Results To date, participants from two phase I studies and two effectiveness trials have participated in MTN-016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. Conclusion In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.

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Section: Introductionmentioning

confidence: 99%

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials

Mhlanga

Noguchi

Balkus

et al. 2017

HIV Clinical Trials

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“…To date, studies have not reported on the uptake of reliable contraceptives after enrolment among women participating in large phase III microbicide clinical trials. Microbicide trials enrol women who are not intending to get pregnant during the course of the trial, yet pregnancy rates in efficacy trials have ranged from 1 to 27 per 100 women-years [ 24 ].…”

Section: Introductionmentioning

confidence: 99%

Uptake of hormonal contraceptives and correlates of uptake in a phase III clinical trial in rural South Western Uganda

et al. 2017

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BackgroundUse of a reliable contraception method has become an inclusion criterion in prevention trials to minimize time off product. We report on hormonal contraceptive prevalence, uptake, sustained use and correlates of use in the Microbicides Development Programme (MDP 301) trial at the Masaka Centre in Uganda.MethodsHIV negative women in sero-discordant relationships were enrolled and followed-up for 52 to 104 weeks from 2005 to 2009. Contraceptive use data was collected through self-report at baseline and dispensing records during follow-up. Hormonal contraceptives were promoted and provided to women that were not using a reliable method at enrolment. Baseline contraceptive prevalence, uptake and sustained use were calculated. Uptake was defined as a participant who reported not using a reliable method at enrolment and started using a hormonal method at any time after. Logistic regression models were fitted to investigate predictors of hormonal contraceptive uptake.ResultsA total of 840 women were enrolled of whom 21 aged ≥50 years and 12 without follow-up data were excluded; leaving 807 (median age 31 IQR 26–38) in this analysis. At baseline, 228 (28%) reported using a reliable contraceptive; 197 hormonal, 28 female-sterilisation, two IUCD and one hysterectomy. As such 579 were not using a reliable contraceptive at enrolment, of whom 296 (51%) subsequently started using a hormonal contraceptive method; 253 DMPA, four oral pills, and two norplant. Overall 193 (98%) existing users and 262 (88%) new users sustained use throughout follow-up. Independent correlates of hormonal contraceptive uptake were: younger women ≤30 years, aOR = 2.5, 95% CI: 1.7–3.6 and reporting not using contraceptives at baseline due to lack of access or money, breastfeeding or other reasons, in comparison to women who reported using unreliable method.ConclusionPromotion and provision of hormonal contraception doubled the proportion of women using a reliable method of contraception. Uptake was pronounced among younger women and those not previously using a reliable method because of lack of access or money, and breastfeeding. Promotion and provision of hormonal contraceptives in trials that require the interruption or discontinuation of investigational products during pregnancy is important to reduce the time off product.Trial registrationProtocol Number ISRCTN64716212.

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“…Though women switched between contraceptive methods, it was encouraging that the switches were within reliable methods and women sustained use of these methods throughout follow up. Uptake and sustained use coupled with higher baseline use of reliable methods than that in the general population could have played a role in the relatively lower proportion of pregnancy than that observed in other HIV prevention trials 20 . Seven women got pregnant while using reliable contraceptives in the trial.…”

Section: Discussionmentioning

confidence: 96%

“…Previous HIV prevention trials in non-fishing communities in Africa (East, West and Southern Africa) have shown that reliable contraceptive use is low, ranging between 5% to 28% 12,16–19 . In a 2013 review of microbicide trials in Africa the incidence of pregnancy ranged from 4.0 to 64 per 100 women-years 20 . There is little data on uptake of reliable contraception and the impact of contraception on pregnancy during these trials.…”

Section: Introductionmentioning

confidence: 99%

Use of reliable contraceptives and its correlates among women participating in Simulated HIV vaccine efficacy trials in key-populations in Uganda

Abaasa

Todd

Mayanja

et al. 2019

Sci Rep

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To prevent pregnancy in trials, reliable contraceptive use is key. We investigated reliable contraceptive use at baseline and six months in key-populations in Uganda, during two Simulated HIV Vaccine Efficacy trials (SiVETs). SiVETs were nested within observational cohorts of Fisherfolk (2012–2014) and Female sex workers (2014–2017). Women in the observational cohorts were screened and enrolled into the SiVET. The trial administered a licensed Hepatitis B vaccine at 0, 1 and 6 months. Contraceptive use data were recorded at baseline and follow-up clinic visits. Reliable contraceptives (injectable Depot Medroxyprogesterone Acetate (DMPA), implant, pills, and intrauterine device (IUD)) were promoted and provided to women not using a reliable method at enrolment. Overall, 367 women were enrolled. At baseline 203 (55%) reported use of reliable contraceptive. Of the 164 women not using a reliable method at enrolment, 131 (80%) started using them during follow-up bringing the overall number to 334 (91%) at the end of follow-up. Young age (≤35 years) was an independent predictor of reliable contraceptive use at both time points while other factors varied. Promotion and provision of reliable contraceptives increased the proportion using them and could help reduce the risk of pregnancy in future HIV prevention trials.

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Pregnancy Incidence and Risk Factors among Women Participating in Vaginal Microbicide Trials for HIV Prevention: Systematic Review and Meta-Analysis

Cited by 9 publications

References 25 publications

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials

Uptake of hormonal contraceptives and correlates of uptake in a phase III clinical trial in rural South Western Uganda

Use of reliable contraceptives and its correlates among women participating in Simulated HIV vaccine efficacy trials in key-populations in Uganda

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