Using Enhanced Peer Group Strategies to Support Prevention of Mother to Child HIV Transmission (PMTCT) Option B+ in Uganda
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 540
- Locations
- 2
- Primary Endpoint
- Retention
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years
- •Documentation of pregnancy through clinical assessment or pregnancy test
- •Documentation of confirmed HIV-positive sero-status at the time of screening
- •Accepting to receive option B+ for PMTCT
- •Providing written informed consent to participate in the randomized trial.
- •Agreeing to come the study clinic for scheduled appointments
- •Agreeing to be home visited as needed to ensure follow up
- •Residing within a 20 km radius around the study clinic
- •Not planning to move out of the catchment area within the next 2 years
Exclusion Criteria
- •Social and other circumstances that may prevent the mother from coming back for follow up
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)
Investigators
Philippa Musoke, MBChB, PhD
Site Leader
MU-JHU CARE