Advancing HIV research with pregnant women

Abstract

Objective Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. Methods We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results Experts discussed a breadth of needed research, including safety, efficacy and appropriate dosing of: newer ARVs for pregnant women, emerging preventive strategies, and treatment for co-infections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusions Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy

“…The interview guide was informed by a review of the literature on women’s participation in research during pregnancy, interviews with investigators discussing challenges and opportunities in including pregnant women in HIV-related clinical trials (Krubiner et al, 2016), and consultations with U.S.- and Malawi-based researchers and health care providers.…”

Low HIV incidence in pregnant and postpartum women receiving a community-based combination HIV prevention intervention in a high HIV incidence setting in South Africa

“…An important current knowledge gap is the lack of data regarding the effectiveness of combination HIV prevention interventions during pregnancy and postpartum [ 4 , 26 ]. Evaluating community-level interventions for maternal and neonatal health is also a current research priority [ 27 ].…”

Lessons from PrEP: A Qualitative Study Investigating How Clinical and Policy Experts Weigh Ethics and Evidence When Evaluating Preventive Medications for Use in Pregnant and Breastfeeding Women

“…The global HIV epidemic and the experience with mass inclusion of pregnant women in PMTCT research offers an interesting historical lesson and opportunity to reflect on the importance of including pregnant women in research. The continued high global burden of HIV in women and susceptibility of women to HIV during pregnancy, underscore the need for interventions to prevent HIV acquisition during pregnancy and support reconsideration of policies for including pregnant women in research [ 2 , 3 ]. Without randomized trial evidence for PrEP use in pregnancy, policy-makers and clinicians triangulated evidence to support use and implementation of PrEP in pregnancy.…”