Clinical trial NCT02515370: Friends for Life Circles for Option B Plus
Official title: Using Enhanced Peer Group Strategies to Support Prevention of Mother to Child HIV Transmission (PMTCT) Option B+ in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Option B plus
HIV infected women
Lead sponsor: MU-JHU CARE
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2015-08-04
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Retention
timeFrame: 2 years
measure: Adherence to Option B+ ARV drugs
timeFrame: 2 years
Secondary outcomes:
measure: Infant HIV Free survival
timeFrame: 2 years
measure: Assessing success and sustainability of FLCs group support activities and IGAs
timeFrame: 2 years
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: MUJHU Research Collaboration
Study officials:
affiliation: MU-JHU CARE
name: Philippa Musoke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.