Peer-Led Intervention for HIV Postpartum Care

No longer recruiting at 8 trial locations

Overseen By Florence Momplaisir, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Relocating outside country

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a peer-led program designed to help pregnant and postpartum women living with HIV manage their health more effectively. The program aims to enhance confidence, support, and skills necessary for maintaining HIV care and controlling the virus after childbirth. Participants will attend sessions focused on either adhering to HIV treatment (WISH Adherence) or developing parenting skills (WISH Parenting). Women in their second or third trimester of pregnancy, living with HIV, and able to communicate in English may qualify for the trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could significantly improve support systems for women living with HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this peer-led intervention is safe for postpartum women living with HIV?

Research has shown that women with HIV must remain engaged in their healthcare after childbirth. Studies have found that adhering to HIV medication often becomes more challenging during this period, potentially impacting health. The WISH Adherence program aims to assist by providing support and information to help women maintain their treatment regimen.

This program is safe, as it involves no medical procedures or medications. It includes educational sessions led by a peer facilitator, focusing on conversation and planning. These sessions are generally manageable and have not been associated with any negative effects, as they aim to enhance understanding and support rather than involve physical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer-Led Intervention for HIV Postpartum Care because it focuses on personalized support through structured and unstructured sessions led by peer facilitators. Unlike standard HIV care, which primarily relies on healthcare providers for ART adherence, this approach empowers women by fostering self-efficacy and engagement through peer bonding and individualized planning. The intervention also distinguishes itself by incorporating parenting education, addressing both medical adherence and family dynamics, which is not typical in current treatment protocols. This dual focus aims to improve overall HIV care retention and ART adherence postpartum, potentially leading to better health outcomes for both mothers and their children.

What evidence suggests that this trial's treatments could be effective for postpartum HIV care?

This trial will compare two peer-led interventions for postpartum women with HIV: the WISH Adherence program and the WISH Parenting program. Studies have shown that women with HIV often struggle to maintain their HIV treatment and medical care after childbirth. Research indicates that peer support can be beneficial. In one study, women who participated in a peer-led program were more likely to consistently take their HIV medications. Specifically, they were 1.81 times more likely to adhere to their treatment compared to those who did not participate. This suggests that support from others in similar situations can significantly aid in managing HIV after childbirth. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for women living with HIV who are in their 2nd or 3rd trimester of pregnancy. They must be able to give informed consent, read and speak English, have access to a cell phone, and be at least 16 years old. Women planning to move out of the country within a year after giving birth cannot participate.

Inclusion Criteria

able to provide informed consent including HIPAA authorization to access protected health information

I am 16 years old or older.

You own a mobile phone.

Exclusion Criteria

planning to relocate outside the country within the year following delivery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Intervention

Participants attend 3 face-to-face prenatal sessions with a peer facilitator to address barriers to outcome expectancies and self-efficacy.

Early third trimester

3 visits (in-person)

Postpartum Intervention

Participants attend 2 face-to-face postpartum sessions to develop skills for ART adherence and engagement in HIV care.

Up to 3 months postpartum

2 visits (in-person)

Follow-up

Participants are monitored for retention in care and viral suppression up to 1 year postpartum.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• WISH Adherence
• WISH Parenting

Trial Overview

The study tests a peer-led intervention aimed at pregnant and postpartum women with HIV. It includes prenatal educational sessions in the third trimester and support up until three months after childbirth, focusing on improving care retention and viral suppression.

How Is the Trial Designed?

Group I: Adherence Experimental Treatment 1 Intervention

Women randomized to the adherence arm will attend 3 prenatal sessions and 2 postpartum sessions with a peer facilitator. Each session will be delivered on an individual basis and consist of structured educational content followed by unstructured conversation, allowing the participant to ask questions and actively engage in formulating her plan to be retained in HIV care. The goal of the prenatal sessions is to introduce the intervention, foster bonding, and address outcome expectancies and self-efficacy regarding retention in HIV care postpartum. The postpartum sessions build on outcome expectancies and self-efficacy to develop skills for Antiretroviral therapy (ART) adherence and engagement in HIV care.

Group II: Parenting Active Control 1 Intervention

Women randomized to the parenting control arm will also attend 3 prenatal sessions and 2 postpartum sessions with a peer facilitator. The educational sessions will be focused on parenting and baby care.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The intervention using text reminders and data-informed counseling did not significantly improve overall adherence to antiretroviral therapy (ART) among 133 pregnant women living with HIV in Uganda, with only 16.4% achieving ≥95% adherence compared to 9.1% in the standard care group.

However, participants who actively used the adherence monitors as intended showed better outcomes, indicating that while the overall intervention was ineffective, it may still benefit certain individuals who engage with the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time Feedback to Improve HIV Treatment Adherence in Pregnant and Postpartum Women in Uganda: A Randomized Controlled Trial. Sabin, LL., Simmons, E., Halim, N., et al.[2023]

The IMAGE pilot intervention significantly improved parenting practices among mothers living with HIV, as evidenced by a study involving 62 mothers and their children, with assessments conducted over 12 months.

The intervention not only enhanced parenting behaviors but also positively impacted family outcomes and parent-child relationships, suggesting it is a valuable approach to improve the quality of life for mothers and their families in challenging circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of a parenting and self-care intervention for HIV-positive mothers: the IMAGE program. Murphy, DA., Armistead, L., Payne, DL., et al.[2018]

Since 2001, there has been a 52% decrease in new HIV infections among children, highlighting the effectiveness of current prevention strategies, but these strategies often fail to address the diverse needs of affected families.

A qualitative review of 13 studies suggests that integrating community support and healthcare platforms into PMTCT approaches can improve outcomes by recognizing the complex realities of living with HIV, advocating for a more personalized care model based on 'HIV trajectories.'

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From patient to person: the need for an 'HIV trajectories' perspective in the delivery of prevention of mother-to-child-transmission services. Hsieh, A., Rodrigues, J., Skovdal, M., et al.[2018]

A supportive group intervention for mothers living with HIV significantly reduced parenting stress levels, with both the parenting and health-focused groups showing improvements, but the parenting group had greater benefits for those initially highly stressed.

Among mothers identified as clinically stressed, the parenting intervention led to significant improvements in overall parenting stress scores, highlighting the importance of targeted support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving parental stress levels among mothers living with HIV: a randomized control group intervention study. Johnson, ER., Davies, SL., Aban, I., et al.[2019]

In a study involving 309 pregnant women living with HIV in Kenya, revisions to the Mentor Mother program did not significantly improve medication adherence to antiretroviral therapy during pregnancy and postpartum, with only a small percentage achieving the desired adherence levels.

Despite the lack of improvement in medication adherence, over 90% of infants in both the standard care and intervention groups received at least one HIV test, although timely testing according to guidelines was infrequent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of revised peer-counselor support on the PMTCT cascade of care: results from a cluster-randomized trial in Kenya (the EMMA study). Larson, BA., Tsikhutsu, I., Bii, M., et al.[2023]

This study will evaluate the effectiveness of a package of community interventions aimed at improving the demand and uptake of PMTCT services among HIV-positive pregnant and postpartum women across three countries (Swaziland, Uganda, and Zimbabwe) with a total of 45 health facilities involved.

The primary outcome will be the return of HIV-exposed infants for early infant diagnosis, with secondary outcomes including antenatal care attendance and male partner HIV testing, highlighting the study's focus on comprehensive maternal and child health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial. Woelk, GB., Kieffer, MP., Walker, D., et al.[2022]

In a study involving interviews and observations of HIV-infected and uninfected women in South Africa, peer counseling for infant feeding was met with mixed feelings; while some women valued the emotional support, others expressed fear and distrust towards the peer counselors.

The research highlights significant contextual barriers that peer counselors face, which could impact the effectiveness of infant-feeding counseling in areas with high HIV prevalence, emphasizing the need for better support systems for HIV-infected mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Peer but not peer": considering the context of infant feeding peer counseling in a high HIV prevalence area. Nor, B., Zembe, Y., Daniels, K., et al.[2009]

A study involving 15 interviews with low-income black and Hispanic women revealed that social support and concern for their infants significantly help women living with HIV stay engaged in care and adhere to antiretroviral therapy (ART).

The findings suggest that a peer mentoring program could be an effective intervention to improve postpartum retention in HIV care, as participants expressed that such support would help them overcome challenges like stigma and isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Acceptability of a Peer Mentor Mother Intervention to Improve Retention in Care of Postpartum Women Living with HIV. Akinde, Y., Groves, AK., Nkwihoreze, H., et al.[2020]

Peer adherence support programs for antiretroviral treatment (ART) did not show significant overall differences in CD4 cell counts between patients receiving this support and those receiving standard care, based on a study of 340 patients in South Africa.

However, the effectiveness of these programs varied significantly depending on family dynamics; they were beneficial in well-functioning families but had negative effects in dysfunctional families, highlighting the need for tailored interventions that consider patients' social contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A peer adherence support intervention to improve the antiretroviral treatment outcomes of HIV patients in South Africa: the moderating role of family dynamics. Wouters, E., Masquillier, C., Ponnet, K., et al.[2022]

Women with HIV are primarily motivated to adhere to antiretroviral therapy during the postpartum period by their commitment to their children's health and preventing perinatal transmission of HIV, as revealed through in-depth interviews with 21 women.

Social support from partners significantly facilitates adherence to therapy by helping with routine pill-taking and reducing feelings of isolation, while barriers such as depression and disrupted schedules can hinder adherence, especially for women with multiple children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome expectancies toward adherence to antiretroviral therapy for pregnant and postpartum women with HIV. Momplaisir, FM., Fortune, K., Nkwihoreze, H., et al.[2022]

The 'Option B+' program in Malawi provides lifelong antiretroviral therapy to all HIV-infected pregnant and breastfeeding women, aiming to improve health outcomes for mothers, infants, and male partners.

The PURE study is a 3-arm trial designed to assess whether peer support in clinics or communities can enhance care-seeking and retention in care for these women and their families, which is crucial for the success of the 'Option B+' initiative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving PMTCT uptake and retention services through novel approaches in peer-based family-supported care in the clinic and community: a 3-arm cluster randomized trial (PURE Malawi). Rosenberg, NE., van Lettow, M., Tweya, H., et al.[2021]

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