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Friends for Life Circles for Option B Plus (FLCs)

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Friends for Life Circles (FLCs).
Sponsored by
MU-JHU CARE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Human Immunodeficiency Virus focused on measuring Option B plus, HIV infected women

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • MUJHU Research Collaboration

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Friends for Life Circles (FLC)

Standard of Care (SOC)

Arm Description

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

Normal standard of care and follow up. The standard care provided in the clinic will be provided for the control arem

Outcomes

Primary Outcome Measures

Retention
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
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

Infant HIV Free survival
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
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

Full Information

First Posted
July 30, 2015
Last Updated
March 14, 2023
Sponsor
MU-JHU CARE
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02515370
Brief Title
Friends for Life Circles for Option B Plus
Acronym
FLCs
Official Title
Using Enhanced Peer Group Strategies to Support Prevention of Mother to Child HIV Transmission (PMTCT) Option B+ in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MU-JHU CARE
Collaborators
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
Option B plus, HIV infected women

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Friends for Life Circles (FLC)
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Arm Description
Normal standard of care and follow up. The standard care provided in the clinic will be provided for the control arem
Intervention Type
Other
Intervention Name(s)
Friends for Life Circles (FLCs).
Intervention Description
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 Outcome Measure Information:
Title
Retention
Description
in care will be measured as 1 minus proportion of women lost to follow-up at 24 months postpartum
Time Frame
2 years
Title
Adherence to Option B+ ARV drugs
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Infant HIV Free survival
Description
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
Time Frame
2 years
Title
Assessing success and sustainability of FLCs group support activities and IGAs
Description
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
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippa Musoke, MD PhD
Organizational Affiliation
MU-JHU CARE
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUJHU Research Collaboration
City
Kampala
ZIP/Postal Code
23491
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
34481464
Citation
Gabagaya G, Rukundo G, Amone A, Wavamunno P, Namale-Matovu J, Lubega I, Nakabiito C, Namukwaya Z, Nolan M, Malamba SS, King R, Homsy J, Fowler MG, Musoke P. Prevalence of undetectable and suppressed viral load in HIV-infected pregnant women initiating Option B+ in Uganda: an observational study nested within a randomized controlled trial. BMC Infect Dis. 2021 Sep 4;21(1):907. doi: 10.1186/s12879-021-06608-4.
Results Reference
derived

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Friends for Life Circles for Option B Plus

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