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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retention in Care up to 1 year postpartum
Secondary outcome measures
Viral Suppression up to 1 year postpartum
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 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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,994 Previous Clinical Trials
42,878,996 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
376 Previous Clinical Trials
1,214,896 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 16 years old or older.You own a mobile phone.
Research Study Groups:
This trial has the following groups:- Group 1: Adherence
- Group 2: Parenting
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest participant count for this experiment?
"Correct. According to clinicaltrials.gov, this medical study is actively recruiting patients and was published on March 3rd 2020 with the latest update made two years later on March 14th 2022. Currently 260 participants are needed from a single site."
Answered by AI
Are researchers currently recruiting for this scientific experiment?
"As per the records on clinicaltrials.gov, this experiment is still actively seeking participants. This study was listed publicly since March 3rd 2020 and underwent its most recent editing session on March 14th 2022."
Answered by AI
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