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

HIV/AIDS Clinical Trial

— OPAL-Aim 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862857
• Other study ID #: 22-37054
• Secondary ID: 1R01AA030464-01
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: May 2025

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Kara Marson, MPH
• Phone: 650-346-5774
• Email: kara.marson[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

[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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• HIV-focused mobilization
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
• Multi-disease-focused mobilization
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

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute (KEMRI)	Mbita
Uganda	Infectious Diseases Research Collaboration (IDRC)	Mbarara

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, Makerere University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of California, Berkeley

Countries where clinical trial is conducted

Kenya,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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