HIV PreventionMATCHNCT06703060
A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women
A study testing Peer Navigation Group in people with HIV Prevention and PrEP, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Prevention, PrEP, Women
- What is being tested?
- Peer Navigation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to Feb 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identified Black cisgender woman;
- self-reported HIV-negative status, and
- ≥18 years.
- reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner,
- have at least one substantial HIV risk factor in the past 6 months according to the 2021 Centers for Disease Control (CDC) PrEP Eligibility Guidelines (i.e., HIV-positive sexual partner, recent bacterial Sexually Transmitted Disease (STD), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high HIV prevalence area or network), and
- never taken PrEP
Who cannot join
- non-English speaking and
- currently living with HIV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Project Director, DrPH contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
Principal Investigator, 410-614-2686, twillie2@jhu.edu
About this study
Official title: Trauma-Informed HIV Prevention for Black Women in Baltimore
U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.
- Conditions
- HIV Prevention, PrEP, Women, Intimate Partner Violence (IPV)
- Being tested
- Peer Navigation Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Navigation GroupBehavioural
Participants randomized to the intervention will receive behavioral lifestyle education on topics related to biomedical HIV prevention. This will include 4 group sessions and 4 one-on-one sessions with a peer navigator.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Peer Navigation) | Experimental | Participants randomized to this arm will receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator Receives: Behavioral: Peer Navigation Group |
| Control Group | Placebo comparator | Participants randomized to this group will receive a single group session Receives: Behavioral: Peer Navigation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP initiation
Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.
Measured: Post baseline up to 6 months
Secondary outcomes (1)
PrEP adherence
Biological assess of tenofovir (TFV) levels in client's urine
Measured: 2-months post-randomization, 4-months post-randomization, and 6-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start28 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Tiara C. Willie, PhD, MA, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703060
- Sponsor's protocol ID
- IRB00018632
- Other IDs
- R01MD019178
- Acronym
- MATCH
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy, confidentiality, and ethical considerations. Protecting personal information is essential to comply with privacy laws (e.g., HIPAA) and the terms of informed consent. Sharing such data could breach confidentiality agreements and potentially expose sensitive information, even if anonymized. Additionally, there are concerns about data security, misuse, and the potential harm to participants, which researchers must carefully consider.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-Informed HIV Prevention for Black Women in Baltimore
- ClinicalTrials.gov ID
- NCT06703060
- Acronym / sponsor ID
- MATCH / IRB00018632
- Conditions
- HIV Prevention, PrEP, Women, Intimate Partner Violence (IPV)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 Nov 2024 (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.
U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Peer Navigation) | Experimental | Behavioral: Peer Navigation GroupParticipants randomized to this arm will receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator |
| Control Group | Placebo comparator | Behavioral: Peer Navigation GroupParticipants randomized to this group will receive a single group session |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- self-identified Black cisgender woman;
- self-reported HIV-negative status, and
- ≥18 years.
- reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner,
- have at least one substantial HIV risk factor in the past 6 months according to the 2021 Centers for Disease Control (CDC) PrEP Eligibility Guidelines (i.e., HIV-positive sexual partner, recent bacterial Sexually Transmitted Disease (STD), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high HIV prevalence area or network), and
Key exclusion criteria (2 listed)
- non-English speaking and
- currently living with HIV
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 |
|---|---|---|
| Peer Navigation GroupParticipants randomized to the intervention will receive behavioral lifestyle education on topics related to biomedical HIV prevention. This will include 4 group sessions and 4 one-on-one sessions with a peer navigator. | Behavioural | Control Group, Intervention Group (Peer Navigation) |
Primary outcome
PrEP initiation
Time frame: Post baseline up to 6 months
Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.
1 secondary outcome
PrEP adherence
Time frame: 2-months post-randomization, 4-months post-randomization, and 6-months post-randomization
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 23 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy, confidentiality, and ethical considerations. Protecting personal information is essential to comply with privacy laws (e.g., HIPAA) and the terms of informed consent. Sharing such data could breach confidentiality agreements and potentially expose sensitive information, even if anonymized. Additionally, there are concerns about data security, misuse, and the potential harm to participants, which researchers must carefully consider.
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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.
Project Director, DrPH contact
Tiara C. Willie, PhD, MA principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Navigation Group in people with HIV Prevention and PrEP, run by Johns Hopkins Bloomberg School of Public Health 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?
The sponsor lists 6 inclusion and 2 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 23 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. Some participants in this study may receive a placebo. 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?
Contact Tiara C. Willie, PhD, MA (410-614-2686, twillie2@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP initiation (time frame: Post baseline up to 6 months). 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 23 Mar 2026.