Clinical trial NCT05193942: Type 1 Hybrid Trial of Our Plan - a Brief, Couples-based HIV/STI Prevention Intervention
Official title: Type 1 Hybrid Trial of Our Plan - a Brief, Couples-based HIV/STI Prevention Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2022-01-18
Enrollment: 216
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4-month randomized controlled trial with an informational control condition
Primary purpose: PREVENTION

Brief summary: This webapp, couples-based HIV/STI prevention intervention project will use a Type 1 Hybrid Design Trial to determine efficacy to reduce HIV risk via uptake of evidence-based strategies and a tailored prevention plan among male couples who are in a new relationship (defined as 1 year or less). In addition, the project will be one of the first studies to investigate how intervention usage is associated with the outcomes over time, as well as explore best practices for future implementation and dissemination of such interventions by considering a variety of potential contexts. As such, the project is innovative, timely, and rigorous with sound scientific premise for helping to advance and bridge webapp HIV prevention science with existing community-level services.

Detailed description: The beginning of a relationship (i.e., within first year) is a crucial time for male couples to make decisions about their HIV/STI and sexual health needs. Via a recently completed nation-wide pilot RCT, the theoretically-grounded, couples-based app intervention showed high acceptability and feasibility, and strong promise for encouraging 42 male couples to create a tailored, prevention plan consisting of evidence-based strategies that aligned with the dyad's HIV serostatus. Retention was 86%, signifying that both partners of each couple completed all assessments, used the app intervention as designed, and participated in an individual-level exit interview. Acceptability was \>95%, and confirmed by using three different data sources (quantitative follow-up assessment, paradata from app intervention use, qualitative interview). The app intervention contained 4 modules (M1-M4) and a geo-locator sexual health resource finder. Although relationship partners individually used the app intervention (on their respective smartphones), questions and activities were built in each module to highlight within-couple comparisons and also encouraged couples to participate in discussion activities together. M1 was about enhancing communication and decision-making skills, while M2 focused on prevention strategies including creating a tailored prevention plan. M3 highlighted statistics of the HIV/STI epidemic, and M4 was about stigma and discrimination. Regarding promise, a two-fold increase was observed in the proportion of couples who created a tailored prevention plan when comparing baseline to follow-up assessment data, and while also considering their paradata. The next steps in this line of work would aim to improve the app intervention by integrating some of the acceptability feedback received, such as offering it in English and Spanish and adding content about importance of ART/PrEP adherence. Next steps also include, investigating - via mixed methods - how best to integrate the app intervention with local AIDS-service organizations (ASOs) and Community-based organizations (CBOs) for future scale up and improve use and adherence of evidence-based strategies among sexual minority men. Last but not least, a 4-month, Type 1 Hybrid Trial will be conducted to establish efficacy on couples' creation of a prevention plan, as well as participants' uptake of new evidence-based strategies (e.g., daily PrEP, regular testing, daily ART) and improving adherence of strategies currently in use. Findings from the Type 1 Hybrid Trial would inform best practices for integrating mHealth intervention science with brick-and-mortar services by including perspectives from the target population and ASOs/CBOs. The Type 1 Hybrid Trial study would occur in locations identified in Ending the HIV Epidemic Plan, such as Miami-Dade and Broward Counties in Florida.

Eligibility criteria: Inclusion Criteria:

* self-reported that currently self-identifies as a male
* self-reported in a sexual relationship with another self-identified male
* self-reported relationship length between 1 and 12 months
* self-reported anal sex with relationship partner in past month
* owns and uses an Internet-connected device (smartphone, tablet, computer)
* resides in the U.S.
* self-reported ability to read and understand English-language

Exclusion Criteria:

* Does not meet one or more of the inclusion criteria

Primary outcomes:
measure: Change in creation of a detailed risk-reduction plan by comparing baseline response to month 4 response
timeFrame: Baseline, month 4
measure: Change in number of evidence-based prevention strategies being used over time by comparing baseline response to month 4 response
timeFrame: Baseline, month 4
measure: Change in confidence about using evidence-based prevention strategies over time by comparing baseline response to month 4 response
timeFrame: Baseline, month 4
measure: Change in intention to use evidence-based prevention strategies over time by comparing baseline response to month 4 response
timeFrame: Baseline, month 4
measure: Change in self-efficacy to use evidence-based prevention strategies over time by comparing baseline response to month 4 response
timeFrame: Baseline, month 4
Secondary outcomes:
measure: Change in goal congruence on sexual health by comparing baseline response to month 4 response
timeFrame: Baseline, month 4
measure: Change in mutual constructive communication by comparing baseline response to month 4 response
timeFrame: Baseline, month 4
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References: