HivNCT06056661
Within My Reach (WMR) Adaptation
A study testing WMR in people with Hiv and Violence, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to adapt a relationship education program. The research team is adapting so that it is helpful for Latino sexual minority men. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- WMR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2023to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as Latino/e/x or Hispanic
- Age 18 years or older
- Currently reside in Miami-Dade County or Broward County
- Identify as gay, bisexual, or other non-heterosexual identity
- Identify as a man
- Comfortable speaking English
Who cannot join
- Unable to provide consent
- Deemed that participating would be potentially harmful to the participant or research staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally Adapting Individually-oriented Relationship Education (Within My Reach) for Latino Sexual Minority Men
The purpose of this study is to adapt a relationship education program. The research team is adapting so that it is helpful for Latino sexual minority men.
- Being tested
- WMR
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WMRBehavioural
Participants will complete up to five sessions that will take 2 hours each. Sessions will take place in person. Participants will learn skills related to getting into and out of romantic relationships and identifying and pursuing goals for romantic relationships.
| Study group | Role | What they receive |
|---|---|---|
| WMR group | Experimental | Participants in this group will receive the WMR program for up to 5 weeks. Receives: Behavioral: WMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability, as measured by the Acceptability of Intervention Measure (AIM)
The AIM consists of four questions that assess acceptability. Responses range from 1 (completely disagree) to 5 (completely agree). Scales are created by averaging responses.
Measured: Up to 3 months
Appropriateness, as measured by the Intervention Appropriateness Measure (IAM)
The IAM consists of four questions that assess appropriateness. Responses range from 1 (completely disagree) to 5 (completely agree). Scales are created by averaging responses.
Measured: Up to 3 months
Secondary outcomes (2)
Change in Sexual Risk Composite, as measured by HIV risk assessment
Participants will answer questions about engagement in anal or vaginal sex, sexual partners' HIV status, current pre-exposure prophylaxis (PrEP) use and adherence (if HIV-negative or unknown HIV status), viral load (if living with HIV), A composite score will be calculated to determine whether or not the participant engaged in sexual behavior that could lead to HIV transmission or acquisition. A score of 1 means that the participant engaged in sexual behavior that could lead to HIV acquisition or transmission. A score of 0 means that they did not.
Measured: Baseline compared to up to 3 months
Change in Acceptance of Couple Violence
The outcome will be measured with the five-item general violence subscale from the Acceptance of Couple Violence Scale. The items will be rated on a scale from 1 (strongly disagree) to 4 (strongly agree). Scales are created by averaging responses.
Measured: Baseline compared to up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start27 Oct 2023
- Primary completion16 Jan 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Research Institute
- Responsible party
- Principal investigator, Audrey Harkness, University of Miami
- Investigators
- Audrey Harkness, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056661
- Sponsor's protocol ID
- 20221114
- Status last verified
- May 2024
- First submitted
- 20 Sep 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapting Individually-oriented Relationship Education (Within My Reach) for Latino Sexual Minority Men
- ClinicalTrials.gov ID
- NCT06056661
- Acronym / sponsor ID
- 20221114
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Mental Research Institute
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 28 Sep 2023 (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.
The purpose of this study is to adapt a relationship education program. The research team is adapting so that it is helpful for Latino sexual minority men.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WMR group | Experimental | Behavioral: WMRParticipants in this group will receive the WMR program for up to 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Identify as Latino/e/x or Hispanic
- Age 18 years or older
- Currently reside in Miami-Dade County or Broward County
- Identify as gay, bisexual, or other non-heterosexual identity
- Identify as a man
Key exclusion criteria (2 listed)
- Unable to provide consent
- Deemed that participating would be potentially harmful to the participant or research staff
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 |
|---|---|---|
| WMRParticipants will complete up to five sessions that will take 2 hours each. Sessions will take place in person. Participants will learn skills related to getting into and out of romantic relationships and identifying and pursuing goals for romantic relationships. | Behavioural | WMR group |
Primary outcome
Acceptability, as measured by the Acceptability of Intervention Measure (AIM)
Time frame: Up to 3 months
The AIM consists of four questions that assess acceptability. Responses range from 1 (completely disagree) to 5 (completely agree). Scales are created by averaging responses.
Appropriateness, as measured by the Intervention Appropriateness Measure (IAM)
Time frame: Up to 3 months
The IAM consists of four questions that assess appropriateness. Responses range from 1 (completely disagree) to 5 (completely agree). Scales are created by averaging responses.
2 secondary outcomes
Change in Sexual Risk Composite, as measured by HIV risk assessment
Time frame: Baseline compared to up to 3 months
Change in Acceptance of Couple Violence
Time frame: Baseline compared to up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- 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. This study is not recruiting at the moment.
Audrey Harkness, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WMR in people with Hiv and Violence, run by University of Miami 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: finished, as of the sponsor's last update on 24 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability, as measured by the Acceptability of Intervention Measure (AIM) (time frame: Up to 3 months). The study lists 2 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 24 May 2024.