Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana

HIV Clinical Trial

Official title:

Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796610
• Other study ID #: R34MH121229
• Status: Completed
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 and selected to be a patient's treatment partner.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Botswana	Botswana Harvard AIDS Institute Partnership (BHP)	Gaborone

Sponsors (4)

Lead Sponsor	Collaborator
RAND	Botswana Harvard AIDS Institute Partnership, Children's Mercy Hospital Kansas City, University of Botswana

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Suppression of Patient Participants	Viral suppression will be defined as viral load < 400 cp/ml	6 months
Secondary	Number of Patient Participants Self-Reported as Treatment Adherent	Participants self-reported the percentage of doses taken in the past month; we defined treatment adherence as having taken at least 95% of prescribed doses	3-months post-baseline
Secondary	Perceived Treatment Partner Support	Continuous scores on Nondirective Support scale (0-5); higher = more nondirective support, rated by patient participants	3-months post-baseline