Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana

Sponsor
RAND (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04796610
Collaborator
Botswana Harvard AIDS Institute Partnership (Other), Children's Mercy Hospital Kansas City (Other), University of Botswana (Other)
107
1
2
24.4
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mopati
N/A

Detailed Description

This study will train health care providers to guide unsuppressed HIV positive patients in the selection of a treatment partner. All health care providers at the intervention clinic (e.g., physicians, nurses, peer counselors) will be educated about effective characteristics of treatment partners, and provided with standard guidance about treatment partner selection to deliver to all patients initiating ART or who are not suppressed (however, for increased impact, the investigators will test the intervention only among those not suppressed). The standard guidance will incorporate Motivational Interviewing (MI) strategies, to acknowledge patients' difficulties and offer advice without trying to force the patient to select a treatment partner of a particular type.

The intervention clinic will sponsor group sessions for treatment partners of unsuppressed patients, to educate treatment partners about HIV treatment, and train treatment partners on counseling skills to convey acceptance of and compassion, and to be non-judgmental and non-confrontational. The investigators will train treatment partners in core MI skills of open questions and reflective listening, to avoid confrontations and support patients in developing motivation for adherence. In the training, the investigators will use experiential learning methods to help partners to understand that confronting their partners about poor adherence, while born out of love and concern for patients' health, is ineffective. The investigators do not intend for treatment partners to be proficient in all MI counseling strategies, but the investigators will train treatment partners to use the two core MI skills. Patients and their treatment partners will be asked to attend at least 3 sessions over the 3-month intervention period. The investigators will survey patients and treatment partners at baseline and 3-months post-baseline and collect viral load from clinic records. Intervention feasibility and acceptability will be assessed via mixed methods (e.g., semi- structured interviews with patients, treatment partners, and clinic staff; refusal rates).

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana
Actual Study Start Date :
Jun 17, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Behavioral: Mopati
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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Viral suppression [Baseline to 12 months post-baseline]

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

Secondary Outcome Measures

  1. Self-reported treatment adherence (doses taken) [Baseline to 3-months post-baseline]

    Percent of doses taken in the past month

  2. Treatment partner support [Baseline to 3-months post-baseline]

    Scores on Directive and Nondirective Support scale (0-5)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Botswana Harvard AIDS Institute Partnership (BHP) Gaborone Botswana

Sponsors and Collaborators

  • RAND
  • Botswana Harvard AIDS Institute Partnership
  • Children's Mercy Hospital Kansas City
  • University of Botswana

Investigators

  • Principal Investigator: Laura Bogart, PhD, RAND
  • Principal Investigator: Mosepele Mosepele, MD, MPH, University of Botswana & Botswana Harvard AIDS Institute Partnership

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RAND
ClinicalTrials.gov Identifier:
NCT04796610
Other Study ID Numbers:
  • R34MH121229
First Posted:
Mar 15, 2021
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by RAND

Study Results

No Results Posted as of Apr 19, 2022