Pregnancy, Contraceptive Use, and HIV Acquisition in HPTN 039: Relevance for HIV Prevention Trials Among African Women

Reid, Stewart E.; Dai, Jiyan; Wang, Jing; Sichalwe, Bupe N; Akpomiemie, Godspower; Cowan, Frances M; Delany‐Moretlwe, Sinead; Baeten, Jared M.; Hughes, James P.; Wald, Anna; Celum, Connie

doi:10.1097/qai.0b013e3181bc4869

Cited by 81 publications

(94 citation statements)

References 16 publications

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“…Twenty eligible reports were included in the previous review [41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60], and out of 400 references retrieved in our updated search (Fig. 1), we identified one new eligible subanalysis of a previously included study [61] and two new eligible studies [62,63].…”

Section: All Included Studiesmentioning

confidence: 99%

“…Among 22 included studies (represented by 23 reports), 18 included estimates specific to OCs [41-,47-53,57-60,62,63], 16 included estimates specific to injectable contraception [41,42,[48][49][50][51][52][53][54][55][57][58][59][60]62,63], and two did not distinguish between methods of HC although the investigators noted that most of the HC users used injectables [46,56]. No eligible studies assessed the contraceptive patch, ring, combined injectable, or levonorgestrel IUD.…”

Section: All Included Studiesmentioning

confidence: 99%

“…Of 22 included studies, we considered thirteen "unlikely to inform the primary question" [43][44][45][46][47][48][49][50][51]55,56,58,63], and nine "informative but with important limitations" (Table A2) [41,42,[52][53][54]57,[59][60][61][62]64]. Each of the "informative but with important limitations" studies included or assessed the need for statistical control for some measure of condom use, age, number of sexual partners, and genital symptoms or genital infection.…”

Section: Studies Considered "Informative But With Important Limitations"mentioning

confidence: 99%

“…The other studies reported nonsignificant estimates [ranging from adjusted incidence rate ratio (adjIRR) 0.66, 95% CI 0.09-4.78 to adjHR 1.80, 95% CI 0. 47-5.66] [41,42,53,57,59,60,62,64]. No substantial differences were observed between combined oral contraceptives (COCs) and progestin-only pills (POPs) in the one study that disaggregated these methods [62].…”

Section: Oral Contraceptivesmentioning

confidence: 99%

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Hormonal contraceptive methods and risk of HIV acquisition in women: a systematic review of epidemiological evidence

Polis¹,

Phillips²,

Curtis³

et al. 2014

Contraception

112

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Whether use of various types of hormonal contraception (HC) affect risk of HIV acquisition is a critical question for women's health. For this systematic review, we identified 22 studies published by January 15, 2014 which met inclusion criteria; we classified thirteen studies as having severe methodological limitations, and nine studies as "informative but with important limitations". Overall, data do not support an association between use of oral contraceptives and increased risk of HIV acquisition. Uncertainty persists regarding whether an association exists between depot-medroxyprogesterone acetate (DMPA) use and risk of HIV acquisition. Most studies suggested no significantly increased HIV risk with norethisterone enanthate (NET-EN) use, but when assessed in the same study, point estimates for NET-EN tended to be larger than for DMPA, though 95% confidence intervals overlapped substantially. No data have suggested significantly increased risk of HIV acquisition with use of implants, though data were limited. No data are available on the relationship between use of contraceptive patches, rings, or hormonal intrauterine devices and risk of HIV acquisition. Women choosing progestin-only injectable contraceptives such as DMPA or NET-EN should be informed of the current uncertainty regarding whether use of these methods increases risk of HIV acquisition, and like all women at risk of HIV, should be empowered to access and use condoms and other HIV preventative measures. Programs, practitioners, and women urgently need guidance on how to maximize health with respect to avoiding both unintended pregnancy and HIV given inconclusive or limited data for certain HC methods.

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Section: All Included Studiesmentioning

confidence: 99%

Section: All Included Studiesmentioning

confidence: 99%

Section: Studies Considered "Informative But With Important Limitations"mentioning

confidence: 99%

Section: Oral Contraceptivesmentioning

confidence: 99%

See 2 more Smart Citations

Hormonal contraceptive methods and risk of HIV acquisition in women: a systematic review of epidemiological evidence

Polis¹,

Phillips²,

Curtis³

et al. 2014

Contraception

112

View full text Add to dashboard Cite

show abstract

“…In a systematic review [67], four of nine studies considered informative but with important limitations reported a 1.5 to 2.2 times increased risk of HIV acquisition in women using injectable contraception(DMPA) [3,28,56,87]. The remaining five studies of injectable contraception in the review [39,57,62,71] reported no statistically significant association with risk of HIV acquisition. In the same review [67], only one study reported increased risk of acquisition resulting from the use of oral contraceptive pills (OCPs).…”

Section: Introductionmentioning

confidence: 99%

Assessing the Potential Impact of Hormonal-Based Contraceptives on HIV Transmission Dynamics Among Heterosexuals

2017

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Background: HIV susceptibility linked to hormonal contraception (HC) has been studied before, but with mixed results. Recent findings have prompted the World Health Organisation (WHO), to encourage women who use HC to concurrently use condoms in order to prevent HIV infection in light of possible increased HIV risk of infection associated with hormone based contraceptives. Methods and Findings: A two sex HIV model classifying women into three risk groups consisting of individuals who use condoms, natural methods and hormone based contraceptives is formulated and analysed to assess the effects of various birth control methods on the transmission dynamics of the disease. Our model results showed that women who use HC could be key drivers of the epidemic and that their increased infectivity may be critical in driving the epidemic. Women who use hormone based contraceptives potentially act as a core-group from which men get infected and in turn transmit the disease to other population groups. We fitted the model to HIV prevalence data for Zimbabwe reported by UNAIDS and Zimbabwe Ministry of Health and Child welfare (MoHCW) and used the model fit to project HIV prevalence. Predictions using HIV data for Zimbabwe suggest that a hypothesised increase in susceptibility and infectivity of 2, 3, and 4 fold would result in a 25%, 50% and 100% increase in baseline HIV prevalence projection respectively, thus suggesting possible increased disease burden even in countries reporting plausible HIV prevalence declines. Conclusion:Although a possible causal relationship between HIV susceptibility and HC use remains subject of continuing scientific probe, its inclusion as part of birth control strategy, has been shown in this study, to possibly have significant influence on HIV transmission. If proven, HC use may potentially explain the inordinate spread of HIV within the sub-Saharan Africa region and therefore compel for urgent assessment with a view to reorienting birth control methods in use in settings with generalised epidemics.

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Pregnancy Incidence and Outcomes Among Women Receiving Preexposure Prophylaxis for HIV Prevention

Mugo

Hong

Celum

et al. 2014

JAMA

Self Cite

112

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Importance Antiretroviral pre-exposure prophylaxis (PrEP), using tenofovir disoproxil fumarate and combination tenofovir disoproxil fumarate / emtricitabine, is efficacious for prevention of HIV acquisition. PrEP could reduce periconception HIV risk, but the effect on pregnancy outcomes is not well defined. Objective To assess pregnancy incidence and outcomes among women using PrEP during the periconception period. Design Randomized trial among 1785 HIV serodiscordant heterosexual couples (the Partners PrEP Study) in which the female partner was HIV uninfected that demonstrated that PrEP was efficacious for HIV prevention, conducted between July 2008 and June 2013 at 9 sites in Kenya and Uganda. Intervention Daily oral tenofovir disoproxil fumarate (TDF) (n=598), combination tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) (n=566), or placebo (n=621) through July 2011, when PrEP demonstrated efficacy for HIV prevention; thereafter, participants continued receiving active PrEP, without placebo. Pregnancy testing occurred monthly and study medication was discontinued upon pregnancy detection. Main Outcomes Pregnancy incidence, birth outcomes (pregnancy loss, preterm birth, congenital anomalies), infant growth. Results A total of 431 pregnancies occurred. Pregnancy incidence was 10.0 per 100 person-years among women assigned placebo, 11.9 among those assigned TDF (incidence difference 1.9, 95% confidence interval [CI] −1.1–4.9, p=0.22 versus placebo), and 8.8 among those assigned TDF-FTC (incidence difference −1.3, 95% CI −4.1–1.5, p=0.39 versus placebo). Prior to discontinuation of the placebo treatment group in July 2011, the occurrence of pregnancy loss (96 of 288 pregnancies), was 42.5% for women receiving TDF-FTC compared with 32.3% for those receiving placebo (difference for TDF-FTC versus placebo 10.2%, 95% CI −5.3–25.7, p=0.16) and was 27.7% for those receiving TDF alone (difference versus placebo −4.6%, 95% CI −18.1–8.9, p=0.46). After July 2011, the frequency of pregnancy loss (52 of 143 pregnancies) was 37.5% for TDF-FTC and 36.7% for TDF alone (difference 0.8%, 95% CI −16.8–18.5, p=0.92). Preterm birth and congenital anomalies did not differ significantly for those who received PrEP versus placebo. Infants born to women randomized to PrEP had growth throughout the first year of life not statistically different than placebo and with point estimates that did not suggest growth restriction. Conclusions and Relevance Among HIV serodiscordant heterosexual African couples, differences in pregnancy incidence, birth outcomes, and infant growth were not statistically different for women receiving PrEP with TDF alone or combination TDF-FTC compared to placebo at the time of conception. Given that PrEP was discontinued when pregnancy was detected and that confidence intervals for the birth outcomes were wide, definitive statements about safety of PrEP in the periconception period cannot be made. These results should be discussed with HIV uninfected women receiving PrEP who are considering bec...

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Pregnancy, Contraceptive Use, and HIV Acquisition in HPTN 039: Relevance for HIV Prevention Trials Among African Women

Abstract: Background-Biomedical HIV prevention trials enroll sexually active women at risk of HIV and often discontinue study product during pregnancy. We assessed risk factors for pregnancy and HIV acquisition, and the effect of pregnancy on time off study drug in HPTN 039.

Cited by 81 publications

References 16 publications

Hormonal contraceptive methods and risk of HIV acquisition in women: a systematic review of epidemiological evidence

Hormonal contraceptive methods and risk of HIV acquisition in women: a systematic review of epidemiological evidence

Assessing the Potential Impact of Hormonal-Based Contraceptives on HIV Transmission Dynamics Among Heterosexuals

Pregnancy Incidence and Outcomes Among Women Receiving Preexposure Prophylaxis for HIV Prevention

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