Bradley N Gaynes, MD,University of North Carolina, Chapel Hill
Nivedita L Bhushan, PhD,RTI International
Location
Medical Center
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Person Name
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Contact
124578963
E-mail
abc@123gmail.com
Condition/Disease
Intervention / Treatment
Ages Eligible for Study
Sex
ALL
Age
CHILD, ADULT
Study Information
Study Type
INTERVENTIONAL
Study Result
NO
Study Phase
NA
Study Doc
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Funder Type
OTHER
Outcome Measure
Primary Outcome Measure
Recruitment Rate (Intervention Feasibility) [ Time Frame: Baseline ]
This measure is the ability to successfully enroll adolescents living with HIV (ALWH) in the pilot trial. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).
Number of participants retained in the study (Intervention Feasibility) [ Time Frame: 12 months ]
This measure of feasibility will be measured as the ability to retain adolescents living with HIV (ALWH) in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial), through study completion.
Proportion of sessions attended (Intervention Feasibility) [ Time Frame: 12 Months ]
The number of sessions attended by participants out of total number of sessions offered.
Number of sessions meeting Fidelity Threshold (Intervention Fidelity) [ Time Frame: 12 Months ]
Fidelity to content for sessions will be assessed by a member of the research team using a checklist of intervention characteristics. Intervention fidelity will be measured as the total number of sessions meeting or exceeding expectations for at least 80% of the total number of fidelity checklist items assessed per session.
Overall Satisfaction among Participants (Intervention Acceptability) [ Time Frame: 12 Months ]
Acceptability will be assessed through brief exit interviews with a sample of adolescents living with HIV (ALWH), all study staff, and supervisors. Exit interviews will assess how easy the intervention was to participate in or deliver, the perceived usefulness of the intervention, suggestions for improvement, and will explore contextual factors that impeded or facilitated implementation.
Secondary Outcome Measure
Recruitment Rate (Intervention Feasibility) [ Time Frame: Baseline ]
This measure is the ability to successfully enroll adolescents living with HIV (ALWH) in the pilot trial. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).
Number of participants retained in the study (Intervention Feasibility) [ Time Frame: 12 months ]
This measure of feasibility will be measured as the ability to retain adolescents living with HIV (ALWH) in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial), through study completion.
Proportion of sessions attended (Intervention Feasibility) [ Time Frame: 12 Months ]
The number of sessions attended by participants out of total number of sessions offered.
Number of sessions meeting Fidelity Threshold (Intervention Fidelity) [ Time Frame: 12 Months ]
Fidelity to content for sessions will be assessed by a member of the research team using a checklist of intervention characteristics. Intervention fidelity will be measured as the total number of sessions meeting or exceeding expectations for at least 80% of the total number of fidelity checklist items assessed per session.
Overall Satisfaction among Participants (Intervention Acceptability) [ Time Frame: 12 Months ]
Acceptability will be assessed through brief exit interviews with a sample of adolescents living with HIV (ALWH), all study staff, and supervisors. Exit interviews will assess how easy the intervention was to participate in or deliver, the perceived usefulness of the intervention, suggestions for improvement, and will explore contextual factors that impeded or facilitated implementation.
Other Outcome
Recruitment Rate (Intervention Feasibility) [ Time Frame: Baseline ]
Completion Date
Start Date
2024-01
Primary Completion Date
2024-06
Completion Date
2024-06
Posted Date
Start Date
21
Result First Posted
12/15/2023
Last Update Posted
12/15/2023
Brief Summary
This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.
Description
This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.
Eligibility Criteria
This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.
Inclusion Criteria
age 13-18
diagnosed with HIV (vertically or horizontally)
scored ≥ 13 on the self-reported and previously used BDI-II
living in the clinic's catchment area with intention to remain for > 1 year
willing to provide consent age 18 or 16-17 years old and married (emancipated minors per Malawi law) or assent with parental consent (age 13-17)
age 13-18
Exclusion Criteria
Less than 13 or greater than 18 years of age
living in the clinic's catchment area with intention to remain for > 1 year
willing to provide consent age 18 or 16-17 years old and married (emancipated minors per Malawi law) or assent with parental consent (age 13-17)