Skip to main content
Clinical Trials/NCT02515370
NCT02515370
Completed
Not Applicable

Using Enhanced Peer Group Strategies to Support Prevention of Mother to Child HIV Transmission (PMTCT) Option B+ in Uganda

MU-JHU CARE1 site in 1 country540 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Immunodeficiency Virus
Sponsor
MU-JHU CARE
Enrollment
540
Locations
1
Primary Endpoint
Retention
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The main goal of the study is to support HIV-infected pregnant women initiated on PMTCT Option B+ during antenatal to adhere to lifelong ART and postpartum care visits through an enhanced group peer support intervention called "friends for life circles".

Detailed Description

The overall goal of this implementation research is to improve retention in care and adherence to ART to 2 years postpartum among HIV infected women in urban and rural Uganda choosing PMTCT Option B+. Formative research will first be conducted to assess knowledge and attitudes regarding Option B+ and lifelong ART among PMTCT clients, community members and health workers. The formative research will inform the design of the group peer support intervention. Interventional research will then be conducted randomizing 540 women to either enhanced group peer support with income generating activities called the Friends for Life Circle (FLC) or MOH standard of care counselling with follow-up to 2 years postpartum. Primary outcomes will include retention in health care, ARV adherence and viral suppression at 6 weeks and 24 months postpartum. Secondary outcomes will include participants' health and economic outcomes.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
August 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
MU-JHU CARE
Responsible Party
Principal Investigator
Principal Investigator

Philippa Musoke, MBChB, PhD

Site Leader

MU-JHU CARE

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Retention

Time Frame: 2 years

in care will be measured as 1 minus proportion of women lost to follow-up at 24 months postpartum

Adherence to Option B+ ARV drugs

Time Frame: 2 years

compare maternal antiretroviral drug adherence using self-report, viral load in blood at delivery, 6 weeks, 6 and 24 months postpartum among all HIV-infected pregnant women participating in the study.

Secondary Outcomes

  • Infant HIV Free survival(2 years)
  • Assessing success and sustainability of FLCs group support activities and IGAs(2 years)

Study Sites (1)

Loading locations...

Similar Trials