Friends for Life Circles for Option B Plus

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Other: Friends for Life Circles (FLCs).

• Registration Number: NCT02515370
• Lead Sponsor: MU-JHU CARE

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 Timeline

• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-04
• Study Start: 2016-05
• Primary Completion: 2019-05
• Study Completion: 2020-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 540

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Friends for Life Circles (FLC)	Friends for Life Circles (FLCs).	The intervention will include formation of peer support groups of eight to ten women in the community with incorporation of income generating activities to improve maternal adherence to clinic appointments and life long antiretroviral therapy

Primary Outcome Measures

Name	Time	Method
Retention	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	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 Outcome Measures

Name	Time	Method
Infant HIV Free survival	2 years	also compare infant HIV-free survival at 6 weeks and 18 months among women randomized to the enhanced community-based intervention (FLC) versus the MOH SOC. Infants born to HIV-infected mothers are tested routinely at 6 weeks of; age for HIV DNA by PCR and at 18 months of age by rapid HIV antibody test as part of the national Early Infant HIV Diagnosis program which is standard of care in every government health unit offering postnatal care in Uganda
Assessing success and sustainability of FLCs group support activities and IGAs	2 years	Each FLC will be assessed to see which groups were most successful in developing specific IGAs. The evaluation will be focus on the ability of FLCs to effectively generate income, participant attendance to the circles' IGA-related activities, key skills gained by participants in the circles and the percent increase or decrease in personal and household income

Trial Locations

Locations (1)

MUJHU Research Collaboration; 🇺🇬 Kampala, Uganda