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Getting to Zero Among Black MSM in the American South

Primary Purpose

HIV Infections

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Equity
Social Media Influencers
Intersectional Stigma Reduction
Peer Support
Standard-of-care
Sponsored by
HIV Prevention Trials Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Pre-exposure Prophylaxis (PrEP), Men who have Sex with Men (MSM), Black Men who have Sex with Men (Black MSM), HIV Incidence, Viral Suppression, Status-neutral Approach, Southern United States, Health Equity, Social Media Influencers (SMI), Intersectional Stigma Reduction, Peer Support, Black Treatment Advocates Networks (BTAN), Ending the HIV Epidemic (EHE), Black AIDS Institute (BAI), Culturally Responsive Intersectional Stigma Prevention (CRISP), Integrated Strategy, Community-randomized, Social determinants of health, Community mobilization, Community-based participatory research

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • FHI 360

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Integrated Strategy

Standard-of-care

Arm Description

Black MSM living in intervention communities will have access to the HPTN 096 integrated strategy in addition to standard HIV prevention and care services available in their communities. The integrated strategy includes a combination of four community-, organizational-, and interpersonal-level components designed to impact individual-level outcomes.

Black MSM living in standard-of-care communities will have access to standard HIV prevention and care services available in their communities.

Outcomes

Primary Outcome Measures

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
Viral suppression in Black MSM living with diagnosed HIV
(supportive) HIV viral load measured in the cross-sectional assessments
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
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)

Secondary Outcome Measures

Self-reported HIV Testing behavior in Black MSM
Responses to survey questions collected during the post implementation cross-sectional assessment
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
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
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
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
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
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
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
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
Care quality of Black MSM needs at HCFs participating in CRISP
Aggregated, facility-level independent ratings of HCF workers
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
Responsiveness to Black MSM needs at HCFs participating in CRISP
Self-reported survey data from health care workers who participate in the CRISP component
Responsiveness to Black MSM needs at HCFs participating in CRISP
Aggregated, facility-level independent ratings of HCF workers
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

Full Information

First Posted
August 19, 2021
Last Updated
May 15, 2023
Sponsor
HIV Prevention Trials Network
Collaborators
Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05075967
Brief Title
Getting to Zero Among Black MSM in the American South
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 14, 2022 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HIV Prevention Trials Network
Collaborators
Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Pre-exposure Prophylaxis (PrEP), Men who have Sex with Men (MSM), Black Men who have Sex with Men (Black MSM), HIV Incidence, Viral Suppression, Status-neutral Approach, Southern United States, Health Equity, Social Media Influencers (SMI), Intersectional Stigma Reduction, Peer Support, Black Treatment Advocates Networks (BTAN), Ending the HIV Epidemic (EHE), Black AIDS Institute (BAI), Culturally Responsive Intersectional Stigma Prevention (CRISP), Integrated Strategy, Community-randomized, Social determinants of health, Community mobilization, Community-based participatory research

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
16 communities will participate in the study, each made up of one or more counties selected from the southern counties and states identified in the Ending the HIV Epidemic (EHE) plan. The communities will be matched into 8 pairs based on population, HIV prevalence and viral suppression. Within each pair, one community will be randomized by public ceremony to receive the components of the integrated strategy, and the other will serve as the standard-of-care (SOC). A starfish sampling approach (the combination of venue-time-based and respondent-driven sampling) will be employed to recruit and enroll individual participants in both intervention and control communities for the cross-sectional assessments.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated Strategy
Arm Type
Experimental
Arm Description
Black MSM living in intervention communities will have access to the HPTN 096 integrated strategy in addition to standard HIV prevention and care services available in their communities. The integrated strategy includes a combination of four community-, organizational-, and interpersonal-level components designed to impact individual-level outcomes.
Arm Title
Standard-of-care
Arm Type
Other
Arm Description
Black MSM living in standard-of-care communities will have access to standard HIV prevention and care services available in their communities.
Intervention Type
Other
Intervention Name(s)
Health Equity
Intervention Description
This community-level structural component will use a standardized, nationally replicable community coalition model (Black Treatment Advocates Networks [BTAN]) to implement an enhanced program model geared to 1) facilitate the effects of the other HPTN 096 interventions by minimizing barriers to HIV testing, PrEP use and viral suppression through sensitizing a local network of service providers (e.g., social, legal, economic sectors) to the needs of Black MSM and maintaining an online platform for exchanging information about the local network that can be used to link Black MSM to resources and services, and 2) amplify the effects of other HPTN 096 components by increasing Black MSM's receptivity to those activities through the integration and promotion of HPTN 096 into the activities of the community coalition model.
Intervention Type
Behavioral
Intervention Name(s)
Social Media Influencers
Intervention Description
In this community-level component, social media influencers (SMI) will be defined for the purposes of this study as users on social media who have established credibility, trust and access to a large audience of Black MSM, and who can persuade them by virtue of their authenticity and reach. SMI will provide tailored messaging for Black MSM in intervention communities on the topics of: HIV/sexually transmitted infections (STI) testing promotion PrEP (and general HIV prevention) awareness and promotion Definition and benefits of viral suppression. Messages may include direction towards health care facilities (HCFs) involved in the intersectional stigma reduction component and information about the virtual peer support platform or BTAN+ events.
Intervention Type
Behavioral
Intervention Name(s)
Intersectional Stigma Reduction
Intervention Description
This organizational-level component will take place in HCFs and is designed to improve cultural responsiveness in the provision of HIV prevention and health care services to Black MSM. It is expected to contribute to a reduction in HIV incidence by creating an affirming and autonomy-supportive healthcare environment that supports Black MSM engagement in HIV-related care and services and that promotes increased HIV/STI testing, PrEP uptake and viral suppression rates.
Intervention Type
Behavioral
Intervention Name(s)
Peer Support
Intervention Description
Peer support workers will be trained and compensated to provide emotional and practical support services. These peer support workers will have shared lived experiences with those whom they are supporting, be self-reflective of those experiences, and know when to share those experiences with others in an appropriate and supportive manner. Once trained, the peer-support workers will have demonstrated competencies in the following domains: HIV, PrEP, nPEP, other HIV prevention options and ART education Adherence to PrEP, ART and medical care HIV/STI testing New HIV diagnosis Addressing intersectional stigma (anti-Black racism, sexual stigmas, HIV-related stigma) Self-care Information about national and local resources and assistance programs, Black MSM-centered health services, and the cost and insurance coverage of medications and medical care Multicultural competency (as it relates to the HIV epidemic for Black MSM in the southern US)
Intervention Type
Other
Intervention Name(s)
Standard-of-care
Intervention Description
Black MSM living in standard-of-care communities will have access to standard HIV prevention and care services available in their communities.
Primary Outcome Measure Information:
Title
Viral suppression in Black MSM living with diagnosed HIV
Description
(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
Time Frame
Measured with data available at the end of the three year intervention
Title
Viral suppression in Black MSM living with diagnosed HIV
Description
(supportive) HIV viral load measured in the cross-sectional assessments
Time Frame
Measured within six months after the end of the three year intervention
Title
PrEP use by Black MSM not living with HIV
Description
(primary) The presence of PrEP agents measured in a dried blood spot (DBS) collected during the cross-sectional assessments
Time Frame
Measured within six months after the end of the three year intervention
Title
PrEP use by Black MSM not living with HIV
Description
(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)
Time Frame
Measured with data available at the end of the three year intervention
Secondary Outcome Measure Information:
Title
Self-reported HIV Testing behavior in Black MSM
Description
Responses to survey questions collected during the post implementation cross-sectional assessment
Time Frame
Measured within six months after the end of the three year intervention
Title
Compare social support in Black MSM in the intervention to the SOC communities
Description
Responses to survey questions collected during the post-implementation cross-sectional assessment
Time Frame
Measured within six months after the end of the three year intervention
Title
Compare intersectional stigma in Black MSM in the intervention to the SOC communities
Description
Responses to survey questions collected during the post-implementation cross-sectional assessment
Time Frame
Measured within six months after the end of the three year intervention
Title
Compare barriers to healthcare in Black MSM in the intervention to the SOC communities
Description
Responses to survey questions collected during the post-implementation cross-sectional assessment
Time Frame
Measured within six months after the end of the three year intervention
Title
Compare individual agency in Black MSM in the intervention to the SOC communities
Description
Responses to survey questions collected during the post-implementation cross-sectional assessment
Time Frame
Measured within six months after the end of the three year intervention
Title
Viral suppression within 6 months of new diagnosis in Black MSM living with HIV
Description
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
Time Frame
Measured with data available at the end of the three year intervention
Title
Tracking EHE implementation activities for Black MSM
Description
Information about EHE implementation activities affecting Black MSM in the EHE plans of all intervention and control communities
Time Frame
Measured with data available at the end of the three year intervention
Title
Tracking EHE implementation activities for Black MSM
Description
Information about EHE implementation activities affecting Black MSM in additional information from local health departments and EHE committees
Time Frame
Measured with data available at the end of the three year intervention
Title
Care quality of Black MSM needs at HCFs participating in CRISP
Description
Self-reported survey data from health care workers who participate in the CRISP component
Time Frame
Measured with data available at the end of the three year intervention
Title
Care quality of Black MSM needs at HCFs participating in CRISP
Description
Aggregated, facility-level independent ratings of HCF workers
Time Frame
Measured with data available at the end of the three year intervention
Title
Care quality of Black MSM needs at HCFs participating in CRISP
Description
Self-reported survey data from Black MSM receiving services at HCFs participating in CRISP activities
Time Frame
Measured with data available at the end of the three year intervention
Title
Responsiveness to Black MSM needs at HCFs participating in CRISP
Description
Self-reported survey data from health care workers who participate in the CRISP component
Time Frame
Measured with data available at the end of the three year intervention
Title
Responsiveness to Black MSM needs at HCFs participating in CRISP
Description
Aggregated, facility-level independent ratings of HCF workers
Time Frame
Measured with data available at the end of the three year intervention
Title
Responsiveness to Black MSM needs at HCFs participating in CRISP
Description
Self-reported survey data from Black MSM receiving services at HCFs participating in CRISP activities
Time Frame
Measured with data available at the end of the three year intervention

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-identify as a man (inclusive of cisgender and transgender men)
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LaRon Nelson, PhD
Organizational Affiliation
Yale University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chris Beyrer, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert Remien, PhD
Organizational Affiliation
NY State Psychiatric Institute and Columbia University
Official's Role
Study Chair
Facility Information:
Facility Name
FHI 360
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Getting to Zero Among Black MSM in the American South

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