HIV
Conditions
Keywords
HIV, Treatment partner
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).
Interventions
BEHAVIORALMopati
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.
Sponsors
Botswana Harvard AIDS Institute Partnership
Children's Mercy Hospital Kansas City
University of Botswana
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression of Patient Participants | 6 months | Viral suppression will be defined as viral load \< 400 cp/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patient Participants Self-Reported as Treatment Adherent | 3-months post-baseline | 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 |
| Perceived Treatment Partner Support | 3-months post-baseline | Continuous scores on Nondirective Support scale (0-5); higher = more nondirective support, rated by patient participants |
Countries
Botswana
Participant flow
Recruitment details
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.
Pre-assignment details
COVID-19 was a large challenge to recruitment and study implementation as a whole
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Control Patients Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period. | 30 |
| 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. | 17 |
| 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. | 28 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Control Patients | Total | Control Treatment Partners | Intervention Patients | Intervention Treatment Partners |
|---|---|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 11.6 | 40.5 years STANDARD_DEVIATION 10.8 | 40.1 years STANDARD_DEVIATION 9.5 | 37.0 years STANDARD_DEVIATION 10.4 | 40.8 years STANDARD_DEVIATION 11.2 |
| Non-Directive Support | 4.6 units on a scale STANDARD_DEVIATION 0.7 | 4.6 units on a scale STANDARD_DEVIATION 0.8 | 4.8 units on a scale STANDARD_DEVIATION 0.7 | 4.4 units on a scale STANDARD_DEVIATION 1 | 4.8 units on a scale STANDARD_DEVIATION 0.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 105 Participants | 28 Participants | 30 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Botswana | 30 participants | 105 participants | 28 participants | 30 participants | 17 participants |
| Self-reported Adherence | 23 Participants | 57 Participants | 10 Participants | 18 Participants | 6 Participants |
| Sex: Female, Male Female | 19 Participants | 71 Participants | 22 Participants | 18 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 34 Participants | 6 Participants | 12 Participants | 5 Participants |
| Viral Suppression | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 17 | 0 / 28 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 17 | 0 / 28 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 17 | 0 / 28 |
Outcome results
Primary
Viral Suppression of Patient Participants
Viral suppression will be defined as viral load \< 400 cp/ml
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Patients | Viral Suppression of Patient Participants | 12 Participants |
| Control Patients | Viral Suppression of Patient Participants | 13 Participants |
p-value: 0.4995% CI: [0.1, 2.98]Regression, Logistic
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
Time frame: 3-months post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Patients | Number of Patient Participants Self-Reported as Treatment Adherent | 24 Participants |
| Control Patients | Number of Patient Participants Self-Reported as Treatment Adherent | 22 Participants |
p-value: 0.01195% CI: [1.93, 146.91]Regression, Logistic
Secondary
Perceived Treatment Partner Support
Continuous scores on Nondirective Support scale (0-5); higher = more nondirective support, rated by patient participants
Time frame: 3-months post-baseline
Population: Some participants skipped the scale on the survey assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Patients | Perceived Treatment Partner Support | 4.9 units on a scale | Standard Deviation 0.2 |
| Control Patients | Perceived Treatment Partner Support | 4.5 units on a scale | Standard Deviation 1 |
p-value: 0.0395% CI: [0.07, 0.97]Regression, Linear