HIV/AIDS
Conditions
Keywords
Drinking venues, Biomedical HIV prevention, Uganda, Kenya
Brief 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.
Detailed 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.
Interventions
BEHAVIORALHIV-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
BEHAVIORALMulti-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
Sponsors
University of California, San Francisco
University of California, Berkeley
Makerere University
Infectious Diseases Research Collaboration, Uganda
Kenya Medical Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participant Inclusion Criteria: * adult (≥18 years) * patron or worker at a drinking venue within the study community
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomedical HIV Prevention Uptake at 4 Weeks | Measured 4 weeks after clinic screening visit | The proportion of HIV-negative adults, receiving an Aim 1 mobilization 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. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomedical HIV Prevention Uptake at 8 Weeks | Measured 8 weeks after clinic screening visit | The proportion of HIV-negative adults, receiving an Aim 1 mobilization 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. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues). |
| Biomedical HIV Prevention Uptake at 12 Weeks | Measured 12 weeks after clinic screening visit | 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. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues). |
| HIV Testing Uptake | Measured at clinic screening visit | The proportion of HIV-unknown 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. |
| Yield of Adults With Untreated HIV | Measured at clinic screening visit | The proportion of persons accepting HIV screening 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. |
| Yield of Adults With Heavy Alcohol Use | Measured at clinic screening visit | 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. |
| Adults With Untreated HIV Who Initiate ART | Measured within one week of presenting for clinic-based screening with a recruitment card | 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. |
Countries
Kenya, Uganda
Contacts
PRINCIPAL_INVESTIGATORGabriel Chamie, MD, MPH
University of California, San Francisco
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32 years |
| Patron or worker Patron | 3753 Participants |
| Patron or worker Worker | 473 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4432 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Kenya | 4596 Participants |
| Region of Enrollment Uganda | 4752 Participants |
| Sex: Female, Male Female | 1714 Participants |
| Sex: Female, Male Male | 3295 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,946 | 0 / 3,802 |
| other Total, other adverse events | 0 / 3,946 | 0 / 3,802 |
| serious Total, serious adverse events | 0 / 3,946 | 0 / 3,802 |
Outcome results
None listed