HIV Infections Clinical Trial
Official title:
Getting to Zero Among Black Men Who Have Sex With Men (MSM) in the American South: Testing the Efficacy of an Integrated Strategy
Verified date | May 2023 |
Source | HIV Prevention Trials Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
HPTN 096 is a community-randomized, controlled, hybrid-type III implementation effectiveness study. It is designed to evaluate an integrated strategy approach to increase the uptake and use of pre-exposure prophylaxis (PrEP) and viral suppression rates among Black MSM in the southern United States. A status-neutral approach will be taken such that Black MSM, regardless of HIV status (both those living with and without HIV), will be included in the study.
Status | Enrolling by invitation |
Enrollment | 4800 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years and older |
Eligibility | The baseline and post-implementation assessment participants will be persons who: - Self-identify as Black man (inclusive of cisgender and transgender men) - Self-report a lifetime history of sex with other men - Are at least 15 years of age - Self-report current residence in the community of interest - Are willing and able to provide informed consent - Agree to complete a short questionnaire - Agree to provide two blood samples (one by fingerstick and another by venipuncture). HIV status will not be ascertained prior to participation in these assessments and eligible Black MSM may participate regardless of HIV status. |
Country | Name | City | State |
---|---|---|---|
United States | FHI 360 | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
HIV Prevention Trials Network | Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Viral suppression in Black MSM living with diagnosed HIV | (primary) The ratio of the number of Black MSM living with diagnosed HIV who are virally suppressed (<200 copies/mL) as measured by HIV surveillance data divided by the number of Black MSM living with diagnosed HIV as measured by HIV surveillance data | Measured with data available at the end of the three year intervention | |
Primary | Viral suppression in Black MSM living with diagnosed HIV | (supportive) HIV viral load measured in the cross-sectional assessments | Measured within six months after the end of the three year intervention | |
Primary | PrEP use by Black MSM not living with HIV | (primary) The presence of PrEP agents measured in a dried blood spot (DBS) collected during the cross-sectional assessments | Measured within six months after the end of the three year intervention | |
Primary | PrEP use by Black MSM not living with HIV | (supportive) The ratio of the number of Black men with PrEP prescriptions (from AIDSVu) divided by the number of Black men with PrEP indications (from CDC) | Measured with data available at the end of the three year intervention | |
Secondary | Self-reported HIV Testing behavior in Black MSM | Responses to survey questions collected during the post implementation cross-sectional assessment | Measured within six months after the end of the three year intervention | |
Secondary | Compare social support in Black MSM in the intervention to the SOC communities | Responses to survey questions collected during the post-implementation cross-sectional assessment | Measured within six months after the end of the three year intervention | |
Secondary | Compare intersectional stigma in Black MSM in the intervention to the SOC communities | Responses to survey questions collected during the post-implementation cross-sectional assessment | Measured within six months after the end of the three year intervention | |
Secondary | Compare barriers to healthcare in Black MSM in the intervention to the SOC communities | Responses to survey questions collected during the post-implementation cross-sectional assessment | Measured within six months after the end of the three year intervention | |
Secondary | Compare individual agency in Black MSM in the intervention to the SOC communities | Responses to survey questions collected during the post-implementation cross-sectional assessment | Measured within six months after the end of the three year intervention | |
Secondary | Viral suppression within 6 months of new diagnosis in Black MSM living with HIV | The ratio of the number of Black MSM with HIV newly diagnosed in Year 3 who have a suppressed viral load (VL) within six months of diagnosis as measured by HIV surveillance data divided by the number of Black MSM with HIV newly diagnosed in Year 3 based on HIV surveillance data | Measured with data available at the end of the three year intervention | |
Secondary | Tracking EHE implementation activities for Black MSM | Information about EHE implementation activities affecting Black MSM in the EHE plans of all intervention and control communities | Measured with data available at the end of the three year intervention | |
Secondary | Tracking EHE implementation activities for Black MSM | Information about EHE implementation activities affecting Black MSM in additional information from local health departments and EHE committees | Measured with data available at the end of the three year intervention | |
Secondary | Care quality of Black MSM needs at HCFs participating in CRISP | Self-reported survey data from health care workers who participate in the CRISP component | Measured with data available at the end of the three year intervention | |
Secondary | Care quality of Black MSM needs at HCFs participating in CRISP | Aggregated, facility-level independent ratings of HCF workers | Measured with data available at the end of the three year intervention | |
Secondary | Care quality of Black MSM needs at HCFs participating in CRISP | Self-reported survey data from Black MSM receiving services at HCFs participating in CRISP activities | Measured with data available at the end of the three year intervention | |
Secondary | Responsiveness to Black MSM needs at HCFs participating in CRISP | Self-reported survey data from health care workers who participate in the CRISP component | Measured with data available at the end of the three year intervention | |
Secondary | Responsiveness to Black MSM needs at HCFs participating in CRISP | Aggregated, facility-level independent ratings of HCF workers | Measured with data available at the end of the three year intervention | |
Secondary | Responsiveness to Black MSM needs at HCFs participating in CRISP | Self-reported survey data from Black MSM receiving services at HCFs participating in CRISP activities | Measured with data available at the end of the three year intervention |
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