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Completed

NCT Number: NCT02515370

Friends for Life Circles for Option B Plus

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".

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MUJHU Research Collaboration

Kampala, 23491, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Friends for Life Circles (FLCs).

Other

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

Primary outcomes

  1. 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. 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

  1. 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. 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

Sponsors and collaborators

Lead sponsor

MU-JHU CARE

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study title

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

Acronym: FLCs

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Aug 4, 2015
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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