Friends for Life Circles for Option B Plus (FLCs)

MU-JHU CARE

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Other: Friends for Life Circles (FLCs).

Study type: Interventional

Funder types: Other

Identifiers

NCT02515370

Musoke-R01-080476-Option B+

Details and patient eligibility

About

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".

Full 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.

Enrollment: 540 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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540 participants in 2 patient groups

Friends for Life Circles (FLC)

Experimental group

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

Treatment:

Other: Friends for Life Circles (FLCs).

Standard of Care (SOC)

No Intervention group

Description:

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