Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana

NCT ID: NCT04796610

Last Updated: 2023-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-17

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention patients

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.

Group Type EXPERIMENTAL

Mopati

Intervention Type BEHAVIORAL

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.

Control patients

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention treatment partners

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.

Group Type EXPERIMENTAL

Mopati

Intervention Type BEHAVIORAL

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.

Control treatment partners

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Botswana Harvard AIDS Institute Partnership

OTHER

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role collaborator

University of Botswana

OTHER

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Bogart, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Mosepele Mosepele, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Botswana & Botswana Harvard AIDS Institute Partnership

Locations

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Botswana Harvard AIDS Institute Partnership (BHP)

Gaborone, , Botswana

Site Status

Countries

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Botswana

References

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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.

Reference Type DERIVED
PMID: 37957535 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R34MH121229

Identifier Type: NIH

Identifier Source: org_study_id

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