Friends for Life Circles for Option B Plus

NCT ID: NCT02515370

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Friends for Life Circles (FLC)

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

Group Type EXPERIMENTAL

Friends for Life Circles (FLCs).

Intervention Type 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

Standard of Care (SOC)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

MU-JHU CARE

OTHER

Sponsor Role lead

Responsible Party

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Philippa Musoke, MBChB, PhD

Site Leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippa Musoke, MD PhD

Role: PRINCIPAL_INVESTIGATOR

MU-JHU CARE

Locations

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MUJHU Research Collaboration

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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Amone A, Gabagaya G, Wavamunno P, Rukundo G, Namale-Matovu J, Malamba SS, Lubega I, Homsy J, King R, Nakabiito C, Namukwaya Z, Fowler MG, Musoke P. Enhanced peer-group strategies to support the prevention of mother-to-child HIV transmission leads to increased retention in care in Uganda: A randomized controlled trial. PLoS One. 2024 Apr 19;19(4):e0297652. doi: 10.1371/journal.pone.0297652. eCollection 2024.

Reference Type DERIVED
PMID: 38640123 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34481464 (View on PubMed)

Other Identifiers

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Musoke-R01-080476-Option B+

Identifier Type: -

Identifier Source: org_study_id

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