跳至主要内容
临床试验/NCT06771843
NCT06771843招募中不适用

Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments

San Diego State University1 个研究点 分布在 1 个国家目标入组 716 人开始时间: 2025年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
716
试验地点
1
主要终点
Change in Phosphatidylethanol (PEth) From Baseline

研究概览

简要总结

The investigators developed the Kisoboka ("It is possible") Intervention to address limitations of existing evidence-based interventions to optimize treatment as prevention among men living with HIV who drink alcohol at hazardous levels in "risk environments" such as fishing communities through reductions in hazardous alcohol use, improved adherence to HIV medications and achieving undetectable HIV viral loads.

Social and structural determinants unique to fishing communities interact to create a risk environment where hazardous drinking impedes adherence to HIV medications among men living with HIV, including prevalent social norms of drinking, drinking as a way of experiencing "reward" and connecting with others (e.g. in the context of transactional sex), stressful work conditions, a "live for today" outlook, and a cash-based economy with no traditional savings infrastructure leading to ease of daily expenditure on drinking and sex work. These social and environmental conditions result in high levels of alcohol misuse and HIV risk, poor HIV outcomes, and exacerbation of HIV-associated wellness comorbidities such as poor mental and subjective physical health and food insecurity.

The goal of this study is to learn if the intervention called Kisoboka works to help men in fishing communities reduce hazardous alcohol use, be better able to take the participants HIV medication as prescribed, and have undetectable HIV viral loads. The investigators will compare the Kisoboka intervention to a brief alcohol screening, adherence counseling, and referrals, and to components of the Kisoboka intervention.

Participants will attend intervention counseling sessions according to the study arm to which the participants are randomly assigned. The number of sessions ranges from 1 to 6 over 1 to 16 weeks and are individual only or both individual and group sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •living with HIV;
  • •residing in a fishing community (on most days/nights);
  • •AUDIT-C positive (≥4) indicating potential hazardous drinking;
  • •>6 months since initial antiretroviral treatment (ART) initiation;
  • •not planning to move from the area within the next 6 months;
  • •have their own mobile phone and can be reached via phone.
  • •an indicator of potential suboptimal treatment as prevention (TasP) either:
  • •(i) last HIV viral load test (within 6 months) was detectable (>20) or (ii) last viral load test between 6 and 13 months ago was detectable (>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks;

排除标准

  • •visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
  • •does not speak Luganda or English;
  • •currently receiving a majority of work payments via mobile money/digital payments;
  • •participated in the Kisoboka pilot RCT;
  • •unable to read basic Luganda or English

研究组 & 干预措施

Behavioral Economics (BE)

Experimental

干预措施: Behavioral Economics (Behavioral)

Motivational Interviewing (MI)

Experimental

干预措施: Motivational Interviewing (Behavioral)

Screening and Referral (S&R)

Active Comparator

干预措施: Screening and Referral (Behavioral)

Kisoboka (BE + MI and synergy)

Experimental

干预措施: Kisoboka (Behavioral)

结局指标

主要结局

Change in Phosphatidylethanol (PEth) From Baseline

时间窗: 6 and 12 month follow up

alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks

Number of Participants with very Hazardous Alcohol Use at Baseline, 6, and 12 Month Follow up

时间窗: 6 and 12 month follow up

Combined biomarker self-report outcome. Number of participants with phosphatidylethanol values ≥400ng/mL OR AUDIT-C scores ≥9. AUDIT-C is the Alcohol Use Disorder Identification Test - Concise.

Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 6 and 12 Month Follow up

时间窗: 6 and 12 month follow up

ART levels tested using blood biomarkers with cut points indicating 6 or more doses per week

Number of Participants with Undetectable HIV Viral Loads at baseline, 6, and 12 month follow up

时间窗: 6 and 12 month follow up

HIV viral load laboratory test results showing undetectable viral load per the assay used (e.g., \<20, \<40 copies/ml)

次要结局

  • Change in depressive symptoms from baseline(6 and 12 month follow up)
  • Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months(6 and 12 month follow up)
  • Change in subjective physical health from baseline(6 and 12 month follow up)
  • Number of participants who are food secure at baseline, 6 months, and 12 months(6 and 12 month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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