Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03919695 |
| Other study ID # |
R34AA025891 |
| Secondary ID |
R34AA025891 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 7, 2020 |
| Est. completion date |
July 2022 |
Study information
| Verified date |
June 2021 |
| Source |
San Diego State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Fisherfolk are a high risk population for HIV and are prioritized to receive antiretroviral
treatment (ART) in Uganda, but risky alcohol use among fisherfolk is a barrier to HIV care
engagement; multilevel factors influence alcohol use and poor access to HIV care in fishing
villages, including a lack of motivation, social support, access to savings accounts, and
access to HIV clinics. This project aims to address these barriers, and subsequently reduce
heavy alcohol use and increase engagement in HIV care, through an intervention in which
counselors provide individual and group counseling to increase motivation, while also
addressing structural barriers to care through increased opportunities for savings and
increased social support. This may be a feasible approach to help this hard-to-reach
population reduce drinking and increase access care, which could ultimately reduce mortality
rates, improve treatment outcomes, and through its effect on HIV viral load, decrease the
likelihood of transmitting HIV to others.
Description:
The investigators propose to develop and pilot a brief combination intervention which
addresses the key drivers of alcohol use and barriers to HIV care engagement and ART
adherence in this population. This study addresses these multi-level factors in an
intervention which combines a structural component of changing the mode of work payments from
cash to mobile money, to reduce "cash in the pocket," and increase the accessibility of
savings through mobile phone-based banking services, with behavioral components to change
behavior. For the behavioral components, the study combines and adapt two efficacious
Motivational Interviewing (MI)-based alcohol interventions to the cultural and situational
context of this population: a brief intervention tested in Kenya and an intervention rooted
in behavioral economics which focuses on increasing the extent to which individuals' behavior
is motivated by and consistent with their long-term goals such as saving money for the
future-in which the structural component of the intervention is interwoven. The aims of the
project are to: 1) Combine a promising structural (e.g., reducing "cash in the pocket") and
behavioral intervention to promote reductions in heavy alcohol use, engagement in HIV care,
and ART adherence among HIV+ male fisherfolk. These interventions will be adapted and
tailored to the population to create the proposed KISOBOKA ("It is possible!") intervention.
The investigators will refine the combination intervention through qualitative research with
HIV+ male fisherfolk and community stakeholders and an initial pilot test with 15
participants examining acceptability and feasibility; 2) Pilot the intervention, randomizing
to the KISOBOKA intervention arm (n=80) or to the control arm (n=80, alcohol screening and
referral). The investigators will assess feasibility, acceptability, and preliminary
estimates of the potential for the intervention, as compared to control, to decrease heavy
drinking frequency and improve HIV care engagement and ART adherence through 6 month follow
up.
