HIV InfectionsNCT05075967
Getting to Zero Among HHI MSM in the American South
A study testing Health Access Coalitions, Social Media and Peer Support in people with HIV Infections, run by HIV Prevention Trials Network at 1 site in United States.
Trial summary
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating communities. Read more about this study
- Who is it for?
- Ages 15 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Health Access Coalitions, Social Media and Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Cross-Sectional HHI MSM Client Assessment Inclusion Criteria
- At least 18 years of age
- Man
- Self-reports a lifetime history of anal sex with another man (i.e., at any time in their life)
- Determined to be HHI within the study community per Centers for Disease Control and Prevention surveillance data
- Willing and able to provide consent to participate in the study
- Have a medical visit scheduled during the designated sampling period at a PHASE treatment or prevention healthcare facility
Cross-Sectional HHI MSM Client Assessment Exclusion Criteria
Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the cross-sectional assessment.
There are no co-enrollment restrictions for participation in this assessment.
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HHI MSM Clients In-depth Interviews (IDIs) Inclusion Criteria
- Met inclusion criteria for the cross-sectional HHI MSM client assessment
- Completed the cross-sectional HHI MSM client assessment
- Willing and able to provide assent/consent
HHI MSM Clients IDIs Exclusion Criteria
Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the qualitative interview.
There are no co-enrollment restrictions for these interviews.
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PHASE HCF Staff IDIs Inclusion Criteria
- Is a staff member at a participating PHASE facility
- Participated in at least one PHASE activity (e.g., attended a PHASE Foundation training, participated in Extension of Community Healthcare Outcomes training, member of PHASE quality improvement team)
- Willing and able to provide consent
PHASE HCF Staff IDIs Exclusion Criteria
Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the qualitative interview.
There are no co-enrollment restrictions for these interviews
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Getting to Zero Among Highest HIV Incidence (HHI) Men Who Have Sex With Men (MSM) in the American South: Testing an Integrated Strategy
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating communities. The ultimate goal is to establish a strategy to reduce HIV incidence among HHI MSM in the southern United States (US) by increasing the number of HHI MSM accessing prevention and treatment services, increasing uptake and use of pre-exposure prophylaxis (PrEP) among those living without HIV and increasing retention in care, and thus viral suppression, among those living with HIV.
- Conditions
- HIV Infections
- Being tested
- Health Access Coalitions, Social Media, Peer Support, Promoting Human Autonomy Support & Empathy (PHASE)
- Keywords
- Pre-exposure Prophylaxis (PrEP), HIV Incidence, Viral Suppression, Status-neutral Approach, Southern United States, Social Media Influencers (SMI), Intersectional Stigma Reduction, Peer Support, Ending the HIV Epidemic (EHE), Integrated Strategy, Community-randomized, Social determinants of health, Community mobilization, Community-based participatory research (CBPR), Health Resources and Services Administration (HRSA), Promoting Human Autonomy Support & Empathy (PHASE), Electronic Medical Record (EMR)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Access CoalitionsBehavioural
This component will use a community coalition program as its base model for reducing structural barriers, shaping community social norms and raising awareness to reduce HIV among HHI MSM. This will be achieved through: 1) facilitating a reduction in social, structural, and policy barriers to HIV testing, PrEP, and viral suppression through fostering collective efficacy, promoting norms within the local service sectors (e.g., social, legal, economic, etc.), and advancing advocacy efforts that support the strategic prioritization of access to resources and services for HHI MSM; and 2) amplifying awareness, education, and capacity building around HIV prevention and treatment resources and messaging (including other HPTN 096 components).
Social MediaBehavioural
A robust social media strategy will be used to reach and engage HHI MSM throughout each participating community. Utilizing a multitude of social media communication and marketing tactics, social media content will be used to educate and empower HHI MSM so that they can make informed decisions and behavioral changes to stop HIV acquisition and transmission, with emphasis on accessing HIV prevention and treatment services, the uptake of PrEP and the importance of staying engaged in care and achieving viral suppression. In addition, the strategy will promote other study components, encouraging HHI MSM to engage in care at PHASE healthcare facilities (HCFs), seek help from peer supporters and take advantage of the environmental changes put in place via the health access coalitions.
Peer SupportBehavioural
Peer supporters, who may possess a shared and/or lived experience, will provide HHI MSM with emotional and practical support, using a HIV-status neutral approach, as well as share information on locally available sexual health and HIV-related resources and support services. Peers may provide support in-person or virtually and may be housed at local community-based organizations. In addition, when appropriate, the use of PHASE HCFs will be encouraged for those seeking healthcare services.
Promoting Human Autonomy Support & Empathy (PHASE)Behavioural
The PHASE component is an HCF-level practice improvement program designed to enhance the provision of healthcare services for HHI MSM. PHASE aims to create an autonomy-supportive healthcare environment that supports HHI MSM engagement in HIV-related care and services and helps to promote increased HIV and sexually transmitted infection testing, PrEP and antiretroviral therapy uptake, retention in care, and viral suppression rates for HHI MSM. The primary study outcomes will be collected at all HCFs participating in PHASE.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Strategy | Experimental | HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US. Receives: Behavioral: Health Access Coalitions; Behavioral: Social Media; Behavioral: Peer Support; Behavioral: Promoting Human Autonomy Support & Empathy (PHASE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities.
Number of HHI MSM with a visit at the HCF in the previous 12 months (Source: EMR).
Measured: Month 12
To evaluate whether the HPTN 096 integrated strategy increases retention in care among HHI MSM living with HIV at PHASE healthcare facilities.
Number of HHI MSM living with HIV with at least two HIV medical visits to the HCF at least 90 days apart within the previous 12 months (Source: EMR)
Measured: Month 12
To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for HHI MSM not living with HIV at PHASE healthcare facilities.
Any PrEP prescription among all HHI MSM without HIV with a medical visit at the HCF within the previous 12 months (Source: EMR).
Measured: Month 12
Secondary outcomes (8)
To evaluate whether the HPTN 096 integrated strategy increases viral suppression (<200 copies/mL) in HHI MSM living with HIV at PHASE healthcare facilities.
Viral suppression of the most recent viral load done among all HHI MSM living with HIV who had a viral load measurement at the HCF in the previous 12 months (Source: EMR).
Measured: Month 12
To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, adherence and persistence for HHI MSM not living with HIV at PHASE healthcare facilities.
Self-report of PrEP initiation and adherence in the previous 12 months (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [questionnaires])
Measured: Months 4, 15, 27
To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, adherence and persistence for HHI MSM not living with HIV at PHASE healthcare facilities.
Repeat PrEP prescriptions among HHI MSM not living with HIV in the previous 12 months (Source: EMR).
Measured: Month 12
To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.
Self-reported scale measuring autonomy support (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [questionnaires, healthcare climate section])
Measured: Months 4, 15, 27
To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.
Individual-level qualitative data with a subset of HHI MSM exploring autonomy support (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [qualitative interviews]).
Measured: Month 17 and 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).
Self-reported data related to autonomy support, social support, stigma, barriers to healthcare, individual agency (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [questionnaires])
Measured: Months 4, 15, 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).
Any PrEP prescription in last 12 months for HHI MSM not living with HIV (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [case report forms])
Measured: Months 4, 15, 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).
Viral load suppression and retention in care in last 12 months in HHI MSM living with HIV (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [case report forms]).
Measured: Months 4, 15, 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start10 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US.
- Masking
- None (open label)
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- LaRon Nelson, PhD, Study chair, Yale University School of NursingChris Beyrer, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075967
- Sponsor's protocol ID
- HPTN 096
- Other IDs
- UM1AI068619
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2021
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting to Zero Among Highest HIV Incidence (HHI) Men Who Have Sex With Men (MSM) in the American South: Testing an Integrated Strategy
- ClinicalTrials.gov ID
- NCT05075967
- Acronym / sponsor ID
- HPTN 096
- Conditions
- HIV Infections
- Keywords
- Pre-exposure Prophylaxis (PrEP), HIV Incidence, Viral Suppression, Status-neutral Approach, Southern United States, Social Media Influencers (SMI), Intersectional Stigma Reduction, Peer Support
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating communities. The ultimate goal is to establish a strategy to reduce HIV incidence among HHI MSM in the southern United States (US) by increasing the number of HHI MSM accessing prevention and treatment services, increasing uptake and use of pre-exposure prophylaxis (PrEP) among those living without HIV and increasing retention in care, and thus viral suppression, among those living with HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US.
| Arm | Type | Receives |
|---|---|---|
| Integrated Strategy | Experimental | Behavioral: Health Access Coalitions, Behavioral: Social Media, Behavioral: Peer Support, Behavioral: Promoting Human Autonomy Support & Empathy (PHASE)HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Access CoalitionsThis component will use a community coalition program as its base model for reducing structural barriers, shaping community social norms and raising awareness to reduce HIV among HHI MSM. This will be achieved through: 1) facilitating a reduction in social, structural, and policy barriers to HIV testing, PrEP, and viral suppression through fostering collective efficacy, promoting norms within the local service sectors (e.g., social, legal, economic, etc.), and advancing advocacy efforts that support the strategic prioritization of access to resources and services for HHI MSM; and 2) amplifying awareness, education, and capacity building around HIV prevention and treatment resources and messaging (including other HPTN 096 components). | Behavioural | Integrated Strategy |
| Social MediaA robust social media strategy will be used to reach and engage HHI MSM throughout each participating community. Utilizing a multitude of social media communication and marketing tactics, social media content will be used to educate and empower HHI MSM so that they can make informed decisions and behavioral changes to stop HIV acquisition and transmission, with emphasis on accessing HIV prevention and treatment services, the uptake of PrEP and the importance of staying engaged in care and achieving viral suppression. In addition, the strategy will promote other study components, encouraging HHI MSM to engage in care at PHASE healthcare facilities (HCFs), seek help from peer supporters and take advantage of the environmental changes put in place via the health access coalitions. | Behavioural | Integrated Strategy |
| Peer SupportPeer supporters, who may possess a shared and/or lived experience, will provide HHI MSM with emotional and practical support, using a HIV-status neutral approach, as well as share information on locally available sexual health and HIV-related resources and support services. Peers may provide support in-person or virtually and may be housed at local community-based organizations. In addition, when appropriate, the use of PHASE HCFs will be encouraged for those seeking healthcare services. | Behavioural | Integrated Strategy |
| Promoting Human Autonomy Support & Empathy (PHASE)The PHASE component is an HCF-level practice improvement program designed to enhance the provision of healthcare services for HHI MSM. PHASE aims to create an autonomy-supportive healthcare environment that supports HHI MSM engagement in HIV-related care and services and helps to promote increased HIV and sexually transmitted infection testing, PrEP and antiretroviral therapy uptake, retention in care, and viral suppression rates for HHI MSM. The primary study outcomes will be collected at all HCFs participating in PHASE. | Behavioural | Integrated Strategy |
Primary outcome
To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities.
Time frame: Month 12
Number of HHI MSM with a visit at the HCF in the previous 12 months (Source: EMR).
To evaluate whether the HPTN 096 integrated strategy increases retention in care among HHI MSM living with HIV at PHASE healthcare facilities.
Time frame: Month 12
Number of HHI MSM living with HIV with at least two HIV medical visits to the HCF at least 90 days apart within the previous 12 months (Source: EMR)
To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for HHI MSM not living with HIV at PHASE healthcare facilities.
Time frame: Month 12
Any PrEP prescription among all HHI MSM without HIV with a medical visit at the HCF within the previous 12 months (Source: EMR).
8 secondary outcomes
To evaluate whether the HPTN 096 integrated strategy increases viral suppression (<200 copies/mL) in HHI MSM living with HIV at PHASE healthcare facilities.
Time frame: Month 12
To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, adherence and persistence for HHI MSM not living with HIV at PHASE healthcare facilities.
Time frame: Months 4, 15, 27
To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, adherence and persistence for HHI MSM not living with HIV at PHASE healthcare facilities.
Time frame: Month 12
To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.
Time frame: Months 4, 15, 27
To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.
Time frame: Month 17 and 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).
Time frame: Months 4, 15, 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).
Time frame: Months 4, 15, 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).
Time frame: Months 4, 15, 27
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LaRon Nelson, PhD study chair
Yale University School of Nursing
Chris Beyrer, MD study chair
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Access Coalitions, Social Media and Peer Support in people with HIV Infections, run by HIV Prevention Trials Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities. (time frame: Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.