HIV InfectionsNCT05873855
Acceptability, Feasibility, and Preliminary Impact of a Web-based, HIV Prevention Toolkit With Cisgender Male Couples in Lima, Peru
A study testing Para ti, para mi, para nosotros (P3) in people with HIV Infections and Hiv, run by Florida International University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Hiv, Sexually Transmitted Infections (Not HIV or Hepatitis)
- What is being tested?
- Para ti, para mi, para nosotros (P3)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2022to 30 Jun 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being assigned male at birth and currently identifying as male (cis-gender);
- having had anal sex with each other in the past 3 months;
- 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.";
- being in a relationship with each other for 3 months or longer;
- being at least 18 years of age;
- not having any history of intimate partner violence since their relationship began;
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- self-reporting not feeling coerced by their partner to take part in the study activities;
- having their own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
- living in the Lima metro area and planning to live there for the next 6 months;
- willing to receive an in-person rapid HIV test (if applicable);
- willing to be tested for other STIs and use swabs to self-collect their own specimens; and
- willing to attend an in-person appointment at baseline and at 6 months.
Who cannot join
- -Does not meet one or more of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
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).
Read the 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.
- Conditions
- HIV Infections, Hiv, Sexually Transmitted Infections (Not HIV or Hepatitis), Sexually Transmitted Diseases, Sexual Behavior, Risk Reduction
- Being tested
- Para ti, para mi, para nosotros (P3), Waitlist Control Para ti, para mi, para nosotros (P3)
- Keywords
- prevention, relationship functioning, adherence, prevention strategies
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Hepatitis, Sexual Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para ti, para mi, para nosotros (P3)Behavioural
From day 1 to day 180 (i.e., entire 6-month duration, post baseline) of the pilot trial, participants randomized to the intervention arm will have access to use the five modules as directed. The P3 intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity.
Waitlist Control Para ti, para mi, para nosotros (P3)Behavioural
From day 91 to day 180 (i.e., starting after 3-month assessment) of the pilot trial, participants randomized to the waitlist control condition will have access to use the five modules as directed. The P3 intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | From baseline to 6 months, participants randomized to the intervention arm will have access to the P3 web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur at 3 months and 6 months. Receives: Behavioral: Para ti, para mi, para nosotros (P3) |
| Waitlist Control | Experimental | From baseline to 3-months, participants in the waitlist control condition will have access to the P3 web app for post-baseline assessment of 3 months and the resources section.
From 3 months to 6 months, participants randomized to the waitlist control arm will then have access to the P3 web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessment that will occur at 6 months. Receives: Behavioral: Waitlist Control Para ti, para mi, para nosotros (P3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Participants will be asked if they created a detailed risk-reduction plan that contains evidence-based strategies with their partner at all time points, using a dichotomous measure containing yes/no responses.
Changes in number of individuals and couples who create a detailed risk reduction plan from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Measured: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
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.
Participants will be asked if they created a detailed agreement with their partner at all time points, using a dichotomous measure containing yes/no responses.
Changes in number of individuals and couples who create a detailed sexual agreement from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Measured: baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
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.
Participants will be asked whether they had adhered to their risk reduction plan at all time points.
Changes to categorical responses (yes/no) at individual and couple levels from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Measured: baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Changes in adherence to agreement by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Participants will be asked whether they had adhered to their agreement at all time points.
Changes to categorical responses (yes/no) at individual and couple levels from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Measured: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
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.
Participants will be asked to select which evidence-based HIV/STI prevention strategies they are currently using at all time points.
Changes to categorical responses (yes/no) at individual and couple levels from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Measured: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
Change in HIV incidence by comparing results from testing at baseline to 6-months.
Participants will be asked to provide sample to test for HIV at baseline and 6-months.
Count: New HIV diagnosis via testing at follow-up occurring 6 months after baseline randomization.
Measured: baseline to 6 months
Change in STI incidence by comparing results from testing at baseline to 6-months.
Participants will be asked to provide sample to test for HIV at baseline and 6-months.
Count: New STI diagnosis via testing at follow-up occurring 6 months after baseline randomization.
Measured: baseline to 6 months
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.
Participants will be asked about their MCC patterns at all time points, using a validated theoretical measure containing 11 questions with Likert-type scale responses ranging from 1-9. Higher scores indicate more positive communication patterns.
Changes in mean scores (individual, couple) will be evaluated from baseline to 3-months and 3-months to 6-months.
Measured: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start27 Dec 2022
- Primary completion26 Apr 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6-month pilot randomized controlled trial with delayed, no-attention control condition of 3 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Universidad Peruana Cayetano Heredia
- Responsible party
- Sponsor
- Investigators
- Jason W Mitchell, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873855
- Sponsor's protocol ID
- 5R34MH126776-02
- Status last verified
- Jul 2025
- First submitted
- 15 May 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Findings from aims 1-3 will be shared via presentation(s) at peer-reviewed national and international conferences, such as the International AIDS Conference, IAS, AIDS Impact, and the International Congress of Behavioral Medicine. Findings resulting from the analysis of the data related to the 6-month pilot randomized control trial will be shared as Research Papers in leading, peer-reviewed journals, such as: JMIR Mhealth Uhealth, AIDS and Behavior, JAIDS, and Prevention Science. A de-identified version of the project's final analytic dataset and codebook will be shared and made available via a download link located at the Florida International University Digital Repository.
Publications
Mitchell JW, Bursac Z, Diaz D, Reyes Diaz EM, Silva-Santisteban A, Konda KA. Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mi, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 10;13:e63106. doi: 10.2196/63106.
PubMed 39388228
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Feasibility, and Preliminary Impact of a Web-based, HIV Prevention Toolkit With Cisgender Male Couples in Lima, Peru
- ClinicalTrials.gov ID
- NCT05873855
- Acronym / sponsor ID
- 5R34MH126776-02
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- University of Southern California, Universidad Peruana Cayetano Heredia
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 24 May 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 6-month pilot randomized controlled trial with delayed, no-attention control condition of 3 months.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Para ti, para mi, para nosotros (P3)From baseline to 6 months, participants randomized to the intervention arm will have access to the P3 web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur at 3 months and 6 months. |
| Waitlist Control | Experimental | Behavioral: Waitlist Control Para ti, para mi, para nosotros (P3)From baseline to 3-months, participants in the waitlist control condition will have access to the P3 web app for post-baseline assessment of 3 months and the resources section. From 3 months to 6 months, participants randomized to the waitlist control arm will then have access to the P3 web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessment that will occur at 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- being assigned male at birth and currently identifying as male (cis-gender);
- having had anal sex with each other in the past 3 months;
- 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.";
- being in a relationship with each other for 3 months or longer;
- being at least 18 years of age;
Key exclusion criteria (1 listed)
- -Does not meet one or more of the inclusion criteria
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 |
|---|---|---|
| Para ti, para mi, para nosotros (P3)From day 1 to day 180 (i.e., entire 6-month duration, post baseline) of the pilot trial, participants randomized to the intervention arm will have access to use the five modules as directed. The P3 intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity. | Behavioural | Intervention |
| Waitlist Control Para ti, para mi, para nosotros (P3)From day 91 to day 180 (i.e., starting after 3-month assessment) of the pilot trial, participants randomized to the waitlist control condition will have access to use the five modules as directed. The P3 intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity. | Behavioural | Waitlist Control |
Primary outcome
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.
Time frame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
Participants will be asked if they created a detailed risk-reduction plan that contains evidence-based strategies with their partner at all time points, using a dichotomous measure containing yes/no responses. Changes in number of individuals and couples who create a detailed risk reduction plan from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
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.
Time frame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Participants will be asked if they created a detailed agreement with their partner at all time points, using a dichotomous measure containing yes/no responses. Changes in number of individuals and couples who create a detailed sexual agreement from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
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.
Time frame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Participants will be asked whether they had adhered to their risk reduction plan at all time points. Changes to categorical responses (yes/no) at individual and couple levels from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Changes in adherence to agreement by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Time frame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
Participants will be asked whether they had adhered to their agreement at all time points. Changes to categorical responses (yes/no) at individual and couple levels from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
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.
Time frame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
Participants will be asked to select which evidence-based HIV/STI prevention strategies they are currently using at all time points. Changes to categorical responses (yes/no) at individual and couple levels from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.
Change in HIV incidence by comparing results from testing at baseline to 6-months.
Time frame: baseline to 6 months
Participants will be asked to provide sample to test for HIV at baseline and 6-months. Count: New HIV diagnosis via testing at follow-up occurring 6 months after baseline randomization.
Change in STI incidence by comparing results from testing at baseline to 6-months.
Time frame: baseline to 6 months
Participants will be asked to provide sample to test for HIV at baseline and 6-months. Count: New STI diagnosis via testing at follow-up occurring 6 months after baseline randomization.
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.
Time frame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months
Participants will be asked about their MCC patterns at all time points, using a validated theoretical measure containing 11 questions with Likert-type scale responses ranging from 1-9. Higher scores indicate more positive communication patterns. Changes in mean scores (individual, couple) will be evaluated from baseline to 3-months and 3-months to 6-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 28 Jul 2025.
- Derived from this study: PubMed 39388228Mitchell JW, Bursac Z, Diaz D, Reyes Diaz EM, Silva-Santisteban A, Konda KA. Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mi, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 10;13:e63106. doi: 10.2196/63106.
- Individual participant dataSharing planned: Yes. Findings from aims 1-3 will be shared via presentation(s) at peer-reviewed national and international conferences, such as the International AIDS Conference, IAS, AIDS Impact, and the International Congress of Behavioral Medicine. Findings resulting from the analysis of the data related to the 6-month pilot randomized control trial will be shared as Research Papers in leading, peer-reviewed journals, such as: JMIR Mhealth Uhealth, AIDS and Behavior, JAIDS, and Prevention Science. A de-identified version of the project's final analytic dataset and codebook will be shared and made available via a download link located at the Florida International University Digital Repository.
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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.
Jason W Mitchell, PhD principal investigator
Florida International 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 Para ti, para mi, para nosotros (P3) in people with HIV Infections and Hiv, run by Florida International University 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 12 inclusion and 1 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 28 Jul 2025. 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?
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. (time frame: baseline to 3-months, 3-months to 6-months, and baseline to 6-months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05873855, which also lists 1 linked publication.
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 28 Jul 2025.