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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA030464-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Berkeley | OTHER |
| Makerere University | OTHER |
| Infectious Diseases Research Collaboration, Uganda | OTHER |
| Kenya Medical Research Institute |
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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.
[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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 1: HIV-focused mobilization | Active Comparator | Patrons and workers at drinking venues will be given a recruitment card for free HIV testing at the local clinic. |
|
| Aim 1: Multi-disease-focused mobilization | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV-focused mobilization | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomedical HIV Prevention Uptake at 4 Weeks | 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). | Measured 4 weeks after clinic screening visit |
| Measure | Description | Time Frame |
|---|---|---|
| Biomedical HIV Prevention Uptake at 8 Weeks | 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). | Measured 8 weeks after clinic screening visit |
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Participant Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Chamie, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute (KEMRI) | Mbita | Kenya | ||||
| Infectious Diseases Research Collaboration (IDRC) |
Per our Data Sharing agreement with the NIAAA Data Archive, we will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics, HIV risk, and alcohol use.
Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis.
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Clusters | Patrons and workers at drinking venues were given a mobilization card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy. |
| FG001 | Control Clusters | Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Population includes persons who received a mobilization card and contributed to the pre-specified, primary analysis, which excluded two clusters where <18 cards were distributed
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Clusters | Patrons and workers at drinking venues were given a mobilization card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy. |
| BG001 | Control Clusters |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Biomedical HIV Prevention Uptake at 4 Weeks | 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). | Population includes persons who received a mobilization card and contributed to the pre-specified, primary analysis, which excluded two clusters where <18 cards were distributed | Posted | Mean | 95% Confidence Interval | % of participants | Measured 4 weeks after clinic screening visit | Venue Clusters | Venue Clusters |
|
12 weeks from clinic-based screening
Adverse events were only monitored/assessed among persons who linked to the clinic for HIV screening (n=7748)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Clusters | Patrons and workers at drinking venues were given a mobilization card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Chamie | University of California | 415-476-4082 | 445 | gabriel.chamie@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2025 | Jan 30, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2025 | Jan 30, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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| Multi-disease-focused mobilization | Behavioral | 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 |
|
| 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. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues). | Measured 12 weeks after clinic screening visit |
| HIV Testing Uptake | 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. | Measured at clinic screening visit |
| Yield of Adults With Untreated HIV | 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. | 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 |
| Mbarara |
| Uganda |
Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Patron or worker | Data collection on whether the mobilization card was distributed to a patron of the drinking venue or a venue worker. | Variable was added after study launch; therefore Data are missing from 705 participants - 415 in intervention group, 290 in control group | Count of Participants | Participants |
|
| OG001 | Control Clusters | Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic. |
|
|
| Secondary | Biomedical HIV Prevention Uptake at 8 Weeks | 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). | Population includes persons who received a mobilization card and contributed to the pre-specified, primary analysis, which excluded two clusters where <18 cards were distributed | Posted | Mean | 95% Confidence Interval | % of participants | Measured 8 weeks after clinic screening visit | Venue Clusters | Venue Clusters |
|
|
|
| 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. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues). | Population includes persons who received a mobilization card and contributed to the pre-specified, primary analysis, which excluded two clusters where <18 cards were distributed | Posted | Mean | 95% Confidence Interval | % of participants | Measured 12 weeks after clinic screening visit | Venue Clusters | Venue Clusters |
|
|
|
| Secondary | HIV Testing Uptake | 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. | Not Posted | Measured at clinic screening visit | Participants |
| Secondary | Yield of Adults With Untreated HIV | 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. | Not Posted | Measured at clinic screening visit | Participants |
| 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. | Not Posted | Measured at clinic screening visit | Participants |
| 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. | Not Posted | Measured within one week of presenting for clinic-based screening with a recruitment card | Participants |
| 0 |
| 3,946 |
| 0 |
| 3,946 |
| 0 |
| 3,946 |
| EG001 | Control Clusters | Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic. | 0 | 3,802 | 0 | 3,802 | 0 | 3,802 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|