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Peer-Led Intervention for HIV Postpartum Care

N/A

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

16 years and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 1 year after delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new intervention to help keep pregnant and postpartum women with HIV healthy and improve viral suppression rates postpartum.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an educational and supportive intervention rather than a medical treatment, traditional side effects like those seen with medications are not expected. However, participants may experience emotional or psychological impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 16 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 1 year after delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 1 year after delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 1 year after delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Retention in Care up to 1 year postpartum

Secondary study objectives

Viral Suppression up to 1 year postpartum

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AdherenceExperimental Treatment1 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: ParentingActive Control1 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.

0 / 1Eligibility criteria met