HIVNCT04796610

Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana

A study testing Mopati in people with HIV, run by RAND at 1 site in Botswana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: Mopati
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteBotswana
Study dates: 17 Jun 2021to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Botswana1 site

Botswana Harvard AIDS Institute Partnership (BHP)
Gaborone

Other trials in Botswana

About this study

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.

Read the 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).

Conditions: HIV
Being tested: Mopati
Keywords: HIV, Treatment partner

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MopatiBehavioural
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.

Study groups in NCT04796610
Study group	Role	What they receive
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. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Viral Suppression of Patient Participants
Viral suppression will be defined as viral load < 400 cp/ml
Measured: 6 months

Secondary outcomes (2)

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
Measured: 3-months post-baseline
Perceived Treatment Partner Support
Continuous scores on Nondirective Support scale (0-5); higher = more nondirective support, rated by patient participants
Measured: 3-months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 202131 Aug 2022

First posted15 Mar 2021
Study start17 Jun 2021
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04796610
Sponsor's protocol ID: R34MH121229
Status last verified: Oct 2023
First submitted: 9 Mar 2021
Last updated: 1 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37957535

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana
ClinicalTrials.gov ID: NCT04796610
Acronym / sponsor ID: R34MH121229
Conditions: HIV
Keywords: HIV, Treatment partner
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Botswana Harvard AIDS Institute Partnership, Children's Mercy Hospital Kansas City, University of Botswana
Study start: 17 Jun 2021 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 15 Mar 2021 (actual)
Results: Posted 1 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Intervention patients	Experimental	Behavioral: MopatiUnsuppressed 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.
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	Behavioral: MopatiUnsuppressed 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.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MopatiThe 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.	Behavioural	Intervention patients, Intervention treatment partners

Primary outcome

Viral Suppression of Patient Participants
Time frame: 6 months
Viral suppression will be defined as viral load < 400 cp/ml

2 secondary outcomes

Number of Patient Participants Self-Reported as Treatment Adherent
Time frame: 3-months post-baseline
Perceived Treatment Partner Support
Time frame: 3-months post-baseline

Results and safety

Results posted to the registry on 1 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Patients	30	27
Control Patients	30	30
Intervention Treatment Partners	17	16
Control Treatment Partners	28	27

Primary outcome: Viral Suppression of Patient Participants

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Intervention Patients n = 18	Control Patients n = 16
Value	12	13

Intervention Patients vs Control Patients: Odds Ratio (OR): .55 (95% CI .1 to 2.98), p = 0.49, Regression, Logistic

Population analysed: Viral load was collected from medical records of previous clinic visits. Viral load was only used in analysis if the participant had a viral load measurement between 90 and 180 days after the baseline survey and, if an intervention participant, after the last intervention session. Because medical records often did not include a viral load measurement in the required date range, viral suppression was not available for all participants.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Control	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Intervention - Treatment Partners	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Control - Treatment Partners	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37957535Bogart 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Bogart, PhD principal investigator

RAND

Mosepele Mosepele, MD, MPH principal investigator

University of Botswana & Botswana Harvard AIDS Institute Partnership

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mopati in people with HIV, run by RAND at 1 site in Botswana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral Suppression of Patient Participants (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04796610, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.