NCT04796610

Brief Summary

This study is a pilot test of the Mopati program ("partner" in Setswana), which is a multi-level intervention that guides healthcare providers and patients about treatment partner selection, and trains treatment partners on provision of effective support. The Specific Aims are: (1) To develop a multi-level treatment partner intervention with input from community and healthcare provider stakeholders in Botswana; and (2) To conduct a pilot test of the feasibility, acceptability, and preliminary effects on viral suppression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable hiv

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

March 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 17, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

March 9, 2021

Results QC Date

August 30, 2023

Last Update Submit

October 30, 2023

Conditions

HIV

Keywords

HIVTreatment partner

Outcome Measures

Primary Outcomes (1)

  • Viral Suppression of Patient Participants

    Viral suppression will be defined as viral load \< 400 cp/ml

    6 months

Secondary Outcomes (2)

  • Number of Patient Participants Self-Reported as Treatment Adherent

    3-months post-baseline

  • Perceived Treatment Partner Support

    3-months post-baseline

Study Arms (4)

Intervention patients

EXPERIMENTAL

Unsuppressed HIV patients at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.

Behavioral: Mopati

Control patients

NO INTERVENTION

Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.

Intervention treatment partners

EXPERIMENTAL

Unsuppressed HIV patients at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.

Behavioral: Mopati

Control treatment partners

NO INTERVENTION

Treatment partners will not receive any intervention; treatment partners' patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.

Interventions

MopatiBEHAVIORAL

The intervention will provide training to health care providers on how to guide unsuppressed HIV patients in the selection of treatment partners. The Mopati program will provide education to patients and their treatment partners about HIV treatment and how treatment partners can support patients in treatment adherence.

Intervention patientsIntervention treatment partners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be eligible if they are: 1) 18 years of age or older, 2) On antiretroviral treatment for HIV (ART) and initiated ART at least 6 months prior, and 3 ) Not virally suppressed (one viral load ≥ 400 cp/ml within prior 12 months at time of enrollment).
  • Treatment partners will be eligible if they are 18 years of age or older and selected to be a patient's treatment partner.

You may not qualify if:

  • Patients will not be eligible if they screen positive for HIV-related dementia or if they show ART resistance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Botswana Harvard AIDS Institute Partnership (BHP)

Gaborone, Botswana

Location

Related Publications (1)

  • Bogart LM, Phaladze N, Kgotlaetsile K, Klein DJ, Goggin K, Mosepele M. Pilot Test of Mopati, a Multi-Level Adherence Intervention for People Living with HIV and Their Treatment Partners in Botswana. Int J Behav Med. 2024 Oct;31(5):787-798. doi: 10.1007/s12529-023-10233-7. Epub 2023 Nov 13.

    PMID: 37957535DERIVED

Results Point of Contact

Title
Laura Bogart
Organization
RAND Corporation
lbogart@rand.org
3103930411

Study Officials

  • Laura Bogart, PhD

    RAND

    PRINCIPAL INVESTIGATOR

  • Mosepele Mosepele, MD, MPH

    University of Botswana & Botswana Harvard AIDS Institute Partnership

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 15, 2021

Study Start

June 17, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

November 1, 2023

Results First Posted

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

BO(1)