Clinical trial NCT05873855: Acceptability, Feasibility, and Preliminary Impact of a Web-based, HIV Prevention Toolkit With Cisgender Male Couples in Lima, Peru
Official title: Acceptability, Feasibility, and Preliminary Impact of a Web-based, HIV Prevention Toolkit With Cisgender Male Couples in Lima, Peru
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Hiv
Sexually Transmitted Infections (Not HIV or Hepatitis)
Sexually Transmitted Diseases
Sexual Behavior
Risk Reduction
Keywords: prevention
relationship functioning
adherence
prevention strategies
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Universidad Peruana Cayetano Heredia
First posted: 2023-05-24
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6-month pilot randomized controlled trial with delayed, no-attention control condition of 3 months.
Primary purpose: PREVENTION

Brief summary: This digital couples-based HIV/STI prevention intervention project will determine preliminary efficacy to improve uptake of evidence-based strategies and a tailored prevention plan among cisgender male couples who are in a relationship (defined as greater than 3 months or more).

Detailed description: The project draws on our strong findings from the preliminary work we conducted in Lima. The 3-year project will update and adapt an existing digital health couples-based HIV/STI prevention toolkit intervention that showed promise for reducing couples' HIV risk. The intervention is theoretically grounded in Couples Interdependence Theory for health behavior change. The project is a 6-month pilot randomized control trial with 60 at-risk male couples using a delayed, educational control condition of 3 months. Our Specific Aims are to: 1) Assess feasibility to retain 60 consented and eligible male couples in a 6-month pilot RCT through quantitative measurement of enrollment and retention/attrition rates, and by reason for attrition; 2) Describe acceptability of the adapted toolkit intervention using mixed methods23 from 3 data sources. At last follow-up, partners responses to the Health Information Usability Evaluation Scale24 and other survey items (e.g., 3 things liked best/least about the toolkit, features for improvement) will be captured, along with the additional details they will share about their experiences during the individual-level, qualitative exit interview; 3) Examine preliminary impact of the toolkit intervention on couples': a) formation and adherence to a tailored risk-reduction plan and agreement; b) relationship functioning (e.g., communication); c) use of/adherence to evidence-based HIV/STI prevention strategies; and d) HIV/STI incidence. Preliminary impact will be assessed via changes in couples' outcomes a-d over time between trial arms, and for all couples.

Eligibility criteria: Inclusion Criteria:

1. being assigned male at birth and currently identifying as male (cis-gender);
2. having had anal sex with each other in the past 3 months;
3. referring to each other as being in a relationship, defined as "someone you feel emotionally or romantically committed to above all others, and may be referred to as partner, husband, partner, etc.";
4. being in a relationship with each other for 3 months or longer;
5. being at least 18 years of age;
6. not having any history of intimate partner violence since their relationship began;
7. self-reporting not feeling coerced by their partner to take part in the study activities;
8. having their own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
9. living in the Lima metro area and planning to live there for the next 6 months;
10. willing to receive an in-person rapid HIV test (if applicable);
11. willing to be tested for other STIs and use swabs to self-collect their own specimens; and
12. willing to attend an in-person appointment at baseline and at 6 months.

Exclusion Criteria:

-Does not meet one or more of the inclusion criteria

Primary outcomes:
measure: Changes in the creation of a detailed risk reduction plan by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
timeFrame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
measure: Changes in the creation of a detailed agreement by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
timeFrame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
measure: Changes in adherence to risk-reduction plan by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
timeFrame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
measure: Changes in adherence to agreement by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
timeFrame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
measure: Changes in the number of evidence-based prevention strategies being used over time by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
timeFrame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
measure: Change in HIV incidence by comparing results from testing at baseline to 6-months.
timeFrame: baseline to 6 months
measure: Change in STI incidence by comparing results from testing at baseline to 6-months.
timeFrame: baseline to 6 months
measure: Changes in relationship mutual constructive communication (MCC) patterns by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
timeFrame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Jason W Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References: