Friends for Life Circles for Option B Plus (FLCs)

March 14, 2023 updated by: Philippa Musoke, MBChB, PhD, MU-JHU CARE

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

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda, 23491
        • MUJHU Research Collaboration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Friends for Life Circles (FLC)
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
Other: Friends for Life Circles (FLCs).
The intervention 'Friends for Life Circles" (FLCs) will build dynamic peer group support in the community aimed at supporting maternal adherence to appointment keeping and taking lifetime antiretroviral drugs
No Intervention: Standard of Care (SOC)
Normal standard of care and follow up. The standard care provided in the clinic will be provided for the control arem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: 2 years
in care will be measured as 1 minus proportion of women lost to follow-up at 24 months postpartum
2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant HIV Free survival
Time Frame: 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
2 years
Assessing success and sustainability of FLCs group support activities and IGAs
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MU-JHU CARE

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Philippa Musoke, MD PhD, MU-JHU CARE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Musoke-R01-080476-Option B+

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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