Clinical trial NCT04796610: Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana
Official title: Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Treatment partner
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Botswana Harvard AIDS Institute Partnership
name: Children's Mercy Hospital Kansas City
name: University of Botswana
First posted: 2021-03-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Viral Suppression of Patient Participants
timeFrame: 6 months
Secondary outcomes:
measure: Number of Patient Participants Self-Reported as Treatment Adherent
timeFrame: 3-months post-baseline
measure: Perceived Treatment Partner Support
timeFrame: 3-months post-baseline
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Botswana Harvard AIDS Institute Partnership (BHP)
Study officials:
affiliation: RAND
name: Laura Bogart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Botswana & Botswana Harvard AIDS Institute Partnership
name: Mosepele Mosepele, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: