The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 1)

Study Overview
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Brief Summary
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This study will test innovative interventions to increase uptake and use of biomedical HIV prevention options by engaging women and men at drinking venues in rural Kenya and Uganda in care, while gaining insights into the facilitators, barriers, and cost-effectiveness of these approaches.

Detailed Description
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[BACKGROUND] Alcohol use is a common risk factor for both HIV prevention uptake and retention in sub-Saharan Africa (SSA). Interventions that promote biomedical HIV prevention (PrEP and PEP) among persons with heavy alcohol use and their sexual partners are urgently needed. Alcohol-serving drinking venues play an important role as sites of HIV transmission in SSA and are ideal sites to engage women and men at increased risk of HIV in biomedical prevention services. [OVERVIEW] The investigators have developed a mobilization strategy of integrating HIV testing within multi-disease screening to recruit >2,000 people from drinking venues in Kenya and Uganda. The investigators now need to determine whether multi-disease mobilization can promote uptake of HIV prevention for adults at drinking venues in the context of new biomedical prevention options. The project will rigorously test innovative interventions in Kenya and Uganda to increase uptake of biomedical HIV prevention, and assess facilitators, barriers, and cost-effectiveness of these approaches. Specific Aims: Compare the effectiveness of two mobilization strategies to increase uptake of biomedical HIV prevention among adults at drinking venues. Determine the cost-effectiveness of interventions that increase biomedical HIV prevention uptake among adults at high-risk for HIV who attend drinking venues. The proposed research will address the critical intersection of alcohol use and HIV risk in SSA, by promoting reach and uptake of biomedical HIV prevention and exploring associated facilitators and barriers.

Official Title
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Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: HIV-focused mobilization
* Behavioral: Multi-disease-focused mobilization


Participation Criteria
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Eligibility Criteria
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Participant Inclusion Criteria: adult (≥18 years) patron or worker at a drinking venue within the study community Exclusion Criteria: age <18 years previous participation in the study (may only participate once) inability to consent (including gross inebriation)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aim 1: HIV-focused mobilization<br>Patrons and workers at drinking venues will be given a recruitment card for free HIV testing at the local clinic. | Behavioral: HIV-focused mobilization<br>* Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free HIV testing at the local clinic<br>|
| Experimental: Aim 1: Multi-disease-focused mobilization<br>Patrons and workers at drinking venues will be given a recruitment card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy. | Behavioral: Multi-disease-focused mobilization<br>* Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free health screenings that may include hypertension, diabetes, HIV, malaria (if febrile), and TB (if symptomatic), and pregnancy at the local clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomedical HIV prevention uptake at 4 weeks | The proportion of HIV-negative adults, receiving an Aim 1 recruitment card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. | Measured 4 weeks after clinic screening visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomedical HIV prevention uptake at 8 weeks | The proportion of HIV-negative adults, receiving an Aim 1 recruitment card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. | Measured 8 weeks after clinic screening visit | 
| Biomedical HIV prevention uptake at 12 weeks | The proportion of HIV-negative adults, receiving an Aim 1 recruitment card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. | Measured 12 weeks after clinic screening visit | 
| HIV testing uptake | The proportion of HIV-negative adults, receiving an Aim 1 recruitment card, who accept clinic-based HIV testing at the clinic screening visit. HIV testing will be done in accordance with Kenyan and Ugandan national testing algorithms. Uptake will be recorded on study CRFs. | Measured at clinic screening visit | 
| Yield of adults with untreated HIV | The proportion of persons accepting HIV testing who are identified with newly diagnosed HIV or those who are self-reported to have known HIV infection but out of care and off of ART. HIV testing will be done in accordance with Kenyan and Ugandan national testing algorithms. Uptake, test results, HIV status, and current ART use will be recorded on study CRFs. | Measured at clinic screening visit | 
| Yield of adults with heavy alcohol use | Heavy alcohol use is defined as self-reported AUDIT-C score (a standardized, three question survey) of greater than or equal to 4 for men and greater than or equal to 3 for women. These outcomes will be recorded on study CRFs. | Measured at clinic screening visit | 
| Adults with untreated HIV who initiate ART | The proportion of adults with untreated HIV that initiate ART. Current and prior ART use will be self-reported and recoded on study CRFs. New ART prescriptions will be measured through pill dispensing data and MoH registries. | Measured within one week of presenting for clinic-based screening with a recruitment card | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drinking venues, Biomedical HIV prevention, Uganda, Kenya