NCT02515370

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

July 30, 2015

Last Update Submit

March 14, 2023

Conditions

Human Immunodeficiency Virus

Keywords

Option B plusHIV infected women

Outcome Measures

Primary Outcomes (2)

  • Retention

    in care will be measured as 1 minus proportion of women lost to follow-up at 24 months postpartum

    2 years

  • 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 Outcomes (2)

  • Infant HIV Free survival

    2 years

  • Assessing success and sustainability of FLCs group support activities and IGAs

    2 years

Study Arms (2)

Friends for Life Circles (FLC)

EXPERIMENTAL

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

Other: Friends for Life Circles (FLCs).

Standard of Care (SOC)

NO INTERVENTION

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

Interventions

Friends for Life Circles (FLCs).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

Friends for Life Circles (FLC)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- Social and other circumstances that may prevent the mother from coming back for follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUJHU Research Collaboration

Kampala, 23491, Uganda

Location

Related Publications (2)

  • 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.

    PMID: 38640123DERIVED

  • 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.

    PMID: 34481464DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Philippa Musoke, MD PhD

    MU-JHU CARE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Site Leader

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 4, 2015

Study Start

May 1, 2016

Primary Completion

May 1, 2019

Study Completion

August 1, 2020

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

UG(1)