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| Name | Class |
|---|---|
| Botswana Harvard AIDS Institute Partnership | OTHER |
| Children's Mercy Hospital Kansas City | OTHER |
| University of Botswana | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mopati | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Suppression of Patient Participants | Viral suppression will be defined as viral load < 400 cp/ml | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Perceived Treatment Partner Support |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Bogart, PhD | RAND | Principal Investigator |
| Mosepele Mosepele, MD, MPH | University of Botswana & Botswana Harvard AIDS Institute Partnership | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Botswana Harvard AIDS Institute Partnership (BHP) | Gaborone | Botswana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37957535 | Derived | 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. |
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COVID-19 was a large challenge to recruitment and study implementation as a whole
Note that both patients and treatment partners were recruited and participated in the intervention. However, results are only reported for patients (and not treatment partners) as the primary and secondary trial outcomes apply to patients only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Patients | Unsuppressed patients with HIV 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. |
| FG001 | Control Patients | Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period. |
| FG002 | Intervention Treatment Partners | Unsuppressed patients with HIV 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. |
| FG003 | Control Treatment Partners | Treatment partners of patients at the control clinic who will receive standard of care at the clinic during the intervention assessment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
30 patients in the intervention clinic and 30 patients in the control clinic
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence. The Mopati intervention provides (1) training to health care providers on how to guide unsuppressed HIV patients in the selection of treatment partners and (2) education to patients and their treatment partners about HIV treatment and how treatment partners can support patients in treatment adherence. Note that both patients and treatment partners were recruited and participated in the intervention. However, counts, baseline characteristics, and results are only reported for patients (and not treatment partners) as the primary and secondary trial outcomes apply to patients only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Viral Suppression of Patient Participants | Viral suppression will be defined as viral load < 400 cp/ml | 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. | Posted | Count of Participants | Participants | 6 months |
|
3 months
The definition was similar as the clinicaltrials.gov definition, and additionally included systematic assessment of current intimate partner violence
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Unsuppressed patients with HIV 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Bogart | RAND Corporation | 3103930411 | 7281 | lbogart@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2023 | Aug 12, 2023 | Prot_SAP_000.pdf |
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|
Continuous scores on Nondirective Support scale (0-5); higher = more nondirective support, rated by patient participants |
| 3-months post-baseline |
| Lost to Follow-up |
|
| BG001 | Control Patients | Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period. |
| BG002 | 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 patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Viral Suppression | Patients were not virally suppressed at baseline per eligibility criteria. Treatment partner viral suppression data was not collected from medical records as was done for patients. Note that treatment partners did not have to be HIV-positive to be eligible. | Count of Participants | Participants |
|
| Self-reported Adherence | Adherence measured as self-reported percentage of doses taken in last month, dichotomized as at least 95% of doses taken in last month | 2 intervention patients did not complete the baseline survey and could not be reached after multiple attempts. One control patient declined to respond to this item. Treatment partner adherence was asked only of treatment partners who were HIV-positive (treatment partners did not have to be HIV-positive to be eligible.) One HIV-positive control treatment partner and one HIV-positive intervention treatment partner declined to respond to this item. | Count of Participants | Participants |
|
| Non-Directive Support | Patient perceptions of non-directive support (α = .92) from their treatment partner were assessed with a subscale adapted from the Social Support Inventory. Response options were 1, "not at all typical" to 5, "very typical." Higher values were indicative of greater non-directive support. | 2 intervention patients did not complete baseline survey and could not be reached after multiple attempts. An additional 3 intervention patients declined to respond to this item. Treatment partner non-directive support was only asked of the N=15 treatment partners who were (a) HIV-positive and (b) reported that the patient is also their treatment partner. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control Patients | Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period. |
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|
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| 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 | Posted | Count of Participants | Participants | 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 | Some participants skipped the scale on the survey assessment | Posted | Mean | Standard Deviation | units on a scale | 3-months post-baseline |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Intervention - Treatment Partners | Treatment partners of unsuppressed patients with HIV at the intervention clinic received education on HIV treatment and how treatment partners can support patients in treatment adherence. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG003 | Control - Treatment Partners | Treatment partners of unsuppressed patients with HIV at the control clinic did not receive any intervention. | 0 | 28 | 0 | 28 | 0 | 28 |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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