ReviewThe lancet. HIV2022
Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap.
Review in The lancet. HIV, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03902418 (Evaluation of Pre-Exposure Prophylaxis), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women
Who cites it
23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- The safety of cabotegravir in pregnancy: a systematic review and meta-analysis.BMC infectious diseases · 2025Pooled it
- Comparative risk of adverse perinatal outcomes associated with classes of antiretroviral therapy in pregnant women living with HIV: systematic review and meta-analysis.Frontiers in medicine · 2024Pooled it
- Impact of daily, oral pre-exposure prophylaxis on the risk of bacterial sexually transmitted infections among cisgender women: a systematic review and narrative synthesis.Wellcome open research · 2022Pooled it
- Just4Us: Acceptability and Feasibility of a Woman-Focused Pre-exposure Prophylaxis (PrEP) Randomized Controlled Trial Intervention.Archives of sexual behavior · 2026Article
- Developing a surveillance system for HIV pre-exposure prophylaxis (PrEP) use in pregnancy in Malawi.BMC pregnancy and childbirth · 2026Article
- Construction, operations, and sustainability of maternal and child health pharmacy clinics in China: a national multicenter cross-sectional survey.BMC health services research · 2026Article
- Community-Based Adaptation and Evaluation of a Peer-Led Intervention to Address Alcohol Use and HIV in Pregnant and Breastfeeding Women in South Africa: Protocol for the "Mentor Mothers Plus" Randomized Control Trial.JMIR research protocols · 2025Article
- Preference for Service Delivery for Long-Acting Pre-exposure Prophylaxis for HIV Infection Among Pregnant and Breastfeeding Women in South Africa and Botswana.AIDS and behavior · 2025Article
- Postpartum women's prospective acceptability of long-acting HIV prevention approaches in Kenya: a qualitative study.BMC health services research · 2025Article
- User preferences on long-acting pre-exposure prophylaxis for HIV prevention in Eastern and Southern Africa: a scoping review.BMC public health · 2025Article
- PrEP preferences and early acceptability of injectable cabotegravir among pregnant and lactating people in Cape Town, South Africa: findings from the PrEPared to Choose study.Journal of the International AIDS Society · 2025Article
- From pregnancy to beyond: renewed emphasis on comprehensive HIV prevention in South Africa.AIDS (London, England) · 2025Article
- Antiretroviral Use for HIV Prevention During Pregnancy: The Need to Strengthen Regulatory and Surveillance Systems in Africa.Drug safety · 2025Article
- Preferences for and acceptability of long-acting HIV prevention products among pregnant and lactating women accessing health services in Kenya: a mixed method cross-sectional analysis.BMC infectious diseases · 2025Article
- Preventing perinatal HIV acquisition; current gaps and future perspectives.Current opinion in HIV and AIDS · 2024Review
- Initiation and continued use of oral pre-exposure prophylaxis among pregnant and postpartum women in South Africa (PrEP-PP): a demonstration cohort study.The lancet. HIV · 2024Article
- Perinatal outcomes associated with pre-exposure prophylaxis for HIV prevention during pregnancy: a systematic review and meta-analysis.EClinicalMedicine · 2024Article
- Centring the health of women across the HIV research continuum.The lancet. HIV · 2024Review
- "So that's why I found PrEP to be safest way to protect yourself": exploring IPV experiences and impact on HIV prevention among pregnant and postpartum women in Cape Town, South Africa.BMC public health · 2024Article
- Safety surveillance for PrEP in pregnant and breastfeeding women.Frontiers in reproductive health · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 7 institutions in 3 countries.
Funding
Abstract
Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or non-breastfeeding populations, and six phase 1-3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.