Since the beginning of the HIV epidemic, community engagement and activism have played a critical role in shaping clinical research and drug development. This engagement has been acknowledged as a vital component of successful outcomes by key health agencies, including WHO. 

There are several challenges and barriers to studying agents for HIV treatment and prevention in women of childbearing potential and pregnant women. They are typically not only thinking about their own health, but also the health of their child, and balancing the risks and benefits even in the face of uncertainty. Therefore, engaging the community of women living with HIV is critical to accelerating research in this population.

Stakeholder consultations across treatment and prevention trials broadly agree on several recommendations: 

• Pregnant women and women who become pregnant have the right to make their own choice about participating in research.
• Clear and understandable information must be shared for informed decision making.
• Pregnant women should be included in research in a timely manner.
• Contraception should not be a prerequisite to study participation and women who become pregnant should be able to stay on study drug.
• Pregnant women should be engaged across the lifecycle of trials.

The 2021 WHO call to action to accelerate the study of new drugs for HIV in pregnant and lactating people invites civil society to:  

• engage as partners in the research process, including the identification of research questions, protocol development and implementation;
• take the lead in building community literacy and advocacy for the inclusion of pregnant women in pre-licensure trials; and
• partner with researchers to develop tools to aid communication on the need for trials in pregnancy. 

The call to action recognizes pregnant and lactating people (regardless of their gender identity) as belonging to a complex population better served through inclusion in research with adequate protection and monitoring, rather than through exclusion from research with delays in access to medications. While there is increasing support for this paradigm shift, it is essential that prospective research participants, their partners and families, and their communities – who are influential in their research participation – also understand and support these changes.  

Pregnancy is an important life event, with many individuals, not just the pregnant person, invested in a positive outcome. Community engagement when done effectively can lead to greater support for the pregnant person – who is thinking about her pregnancy, as well as her own health – but also for the inclusion of pregnant people in research that can lead to greater societal benefits for the community at large.  

The Good Participatory Practice guidelines developed by UNAIDS and AVAC in 2007 to provide systematic guidance to clinical research sponsors, funders and implementers on how to effectively engage with stakeholders in the design and conduct of biomedical research. Since the initial launch of these guidelines, they have been adapted for tuberculosis trials and trials of pandemic pathogens including COVID-19, reflecting their value in providing a structured approach to community engagement. This same framework can be applied to engage stakeholders in the development of trials and observational studies that include pregnant and lactating people.  

In a workshop on “Approaches to enhance and accelerate the study of new drugs for HIV and associated infections in pregnant women”, community stakeholders made recommendations regarding how to engage pregnant participants across the life of a trial (Figure 1), incorporating many of the recommendations regarding good participatory practice.

In this section we provide practical examples that illustrate

• approaches to ensuring community engagement in research development; and  
• tools that can be used to enhance communication and community literacy. 

As mentioned elsewhere, although the terms ‘woman’ and ‘mother’ are used in this toolkit, we recognise that some people who experience pregnancy do not identify as women or mothers. This toolkit is meant to be inclusive of all who experience pregnancy, regardless of their gender identity.

Call to action for community stakeholders 

Research for informed choices: accelerating the study of new drugs for HIV in pregnant and breastfeeding women: a call to action. WHO/IMPAACT/CIPHER, 2021. 

Approaches to ensuring community engagement in research development 

These materials provide practical guidance on approaches to engagement with community stakeholders across the lifecycle of a trial. 

Good Participatory Practice guidelines, Guidelines for biomedical HIV prevention trials, second edition. UNAIDS and AVAC, 2011. 

Good participatory practices tools and resources  

The Good Participatory Practice guidelines were developed by UNAIDS and AVAC in 2007 to guide clinical research sponsors, funders and implementers on how to effectively engage with stakeholders in the design and conduct of biomedical research.  

Community engagement in the PURPOSE 1 study 

The PURPOSE 1 study provides an example of early and sustained community engagement in a clinical trial of HIV prevention interventions through the creation of a Global Community Accountability Group (G-CAG). The establishment of this group enabled community involvement throughout the study, starting from the trial design and protocol development stages.

• The PURPOSE 1 Community Accountability Group (poster presentation - PDF, 6 Mb)
• Overview of the inclusion of pregnant and lactating women in the PURPOSE programme (slides - PDF, 8.7 Mb)

What lessons it might teach us? Community engagement in HIV research. Karris MY, Dubé K, Moore AA. Curr Opin HIV AIDS. 2020 Mar;15(2):142-149.  

After over three decades, this article reviews the state of community engagement in HIV research, discusses best practices as supported by literature, explores innovations and identify ongoing gaps in knowledge. It looks at the history of community engagement and makes recommendations to support effective partnerships between academia and community. Although it does not discuss pregnant women specifically, the article highlights good practice and barriers to achieving this. 

Engaging the community of women living with HIV to tailor and accelerate ARV research for pregnant and breastfeeding women. Clayden P, Zech JM, Irvine C, Mahaka IC, and Namiba A (2022). J Int AIDS Soc., 25: e25920.  

This article was informed by a workshop convened by WHO and the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network entitled: “Approaches to Enhance and Accelerate Study of New Drugs for HIV and Associated Infections in Pregnant Women”. The viewpoint is based on discussions on community engagement that took place during this workshop. The workshop focused on pre-licensure trials and studies to determine dosing and safety in pregnant women. Most of the discussions and recommendations are appropriate for all research, while some are particular for trials of new agents. 

From presumptive exclusion towards fair inclusion: perspectives on the involvement of women living with HIV in clinical trials, including stakeholders’ views. Namiba A, Kwardem L, Dhairyawan R, et al. Therapeutic Advances in Infectious Disease. 2022;9.  

Despite making up more than half of the global population of people living with HIV, women are under-represented in HIV treatment, cure, and prevention clinical trials. This article explores the meaningful involvement of women living with HIV in clinical trials from multiple perspectives. It looks at what this means in practice from the perspective of a variety of different stakeholders, including HIV consultants, women living with HIV, and a gender and health policy analyst. 

Including pregnant and breastfeeding people in trials of novel LAED PrEP agents: perspectives from sub-Saharan Africa community stakeholders. White RR, Dyer MC, Hosseinipour MC and Delany-Moretlwe S (2023). J Int AIDS Soc., 26: e26120.  

This article describes the outcome of a community stakeholder consultation on including pregnant and lactating women (and relaxing the contraceptive requirement) in an HIV prevention trial of a long-acting agent. Despite concerns, the community stakeholders recognized the importance of the inclusion of this population in research. With adequate information, the inclusion of pregnant women in trials could lead to earlier access to effective products for this population in the future, and avoid the harms associated with off-label use of drugs where robust data on safety, efficacy and pharmacology are missing. 

Informed choices for pregnant women! New approaches and good practices for studying antiretrovirals in pregnancy. IAS 2021, 18–21 July. Virtual satellite session SA49. Community panel (from 11.28 to 36.27 minutes) 

In this community panel at IAS 2021, we hear the voices of women involved in grassroots treatment literacy and advocacy, trial participants and mothers living with HIV. The messages that pregnant women should be enrolled in clinical trials, where appropriate, and that they should be supported to make their own decisions about participating, as well as the many advantages to the research, are very clear. 

Accelerating investigation of novel therapeutics in pregnancy: from theory to action. AIDS 2022, Satellite session.  

See presentation on ‘Effective and meaningful support of participants in research’.  

In this session we hear from a community representative talking about strategies to include pregnant people in trials.  

Catalyzing Progress in the Inclusion of Pregnant and Lactating People in HIV Prevention Research. Satellite session, HIVR4P Conference, 6-10 October 2024. 
Video recording 

AVAC resources

An Advocate’s Guide to Research in Pregnant and Lactating Populations. AVAC, November 2024.

This resource provides background information on the need for research in pregnant and lactating populations and how advocates can advance inclusion.

Inclusion of Pregnant and Lactating People in HIV Research: What you need to know.  AVAC, November 2023. Podcast.

Pregnant and Lactating People (PLP) in Ongoing HIV Prevention Trials. AVAC, April 2023. Infographic.

Advancing HIV Prevention Research in Pregnant and Lactating People (PLP): Think Tank Report & Action Plan. AVAC, March 2023. Report.

Examples of tools that can be used to enhance communication and community literacy 

HIV Prevention Manual for Pregnant and Breastfeeding Populations. Pangaea Zimbabwe (PDF, 11.5 Mb)

Disclaimer

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