Friends for Life Circles for Option B Plus

Human Immunodeficiency Virus Clinical Trial

— FLCs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515370
• Other study ID #: Musoke-R01-080476-Option B+
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: August 2020

Study information

• Verified date: March 2023
• Source: MU-JHU CARE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: August 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
Uganda	MUJHU Research Collaboration	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
MU-JHU CARE	Johns Hopkins University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	in care will be measured as 1 minus proportion of women lost to follow-up at 24 months postpartum	2 years
Primary	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.	2 years
Secondary	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	2 years
Secondary	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	2 years