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NCT02116049 · ClinicalTrials.gov registry record · NA

Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners

A NA study, sponsored by University of South Florida.

Completed
Registry status
NA
Development phase
340
Enrollment target

NCT02116049: Completed NA study, sponsored by University of South Florida.

NCT02116049 is a NA study that has completed, run by University of South Florida. The registered enrollment target is 340 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02116049, a NA study, has completed, sponsored by University of South Florida.

COMPLETED
Registry status
NA
Development phase
340 participants
Enrollment target

Study Summary

Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an HIV-positive status may be a key factor responsible for male-male HIV transmission. There are no known intervention programs whose primary focus is to help MSM develop requisite skills to disclose their status to casual sexual partners. The development of such interventions is essential because of the numerous repercussions for not disclosing when one is HIV-positive such as legal prosecution and the transmission of HIV. In a previous intervention development study (R21MH067494) the research team created and tested a 4 session intervention found to be promising for increasing disclosure to casual sexual partners. The purpose of the proposed research is to further refine and enhance our HIV disclosure intervention (DI) designed to increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an attention control case management group (ACCM) for HIV-positive MSM; examine the effects of the intervention over time; explore differential treatment responses to the disclosure intervention and ACCM on the basis of ethnicity, age, and education level as well as examine the mediating effect of baseline frequency of sexual activity, severity of substance abuse at baseline, and stigmatized fear on the relationship between intervention type and the outcome. Finally, the investigators will test how treatment engagement, retention and expectations predict subsequent disclosure and risky sexual outcomes.

Primary Outcome

Disclosure to sexual partners is measured at the encounter level (last 5 sexual encounters during the prior 30 day period), and as an aggregate (number of partners disclosed to during the prior 30 day period.

Interventions

  • BEHAVIORAL Disclosure Intervention
  • BEHAVIORAL Attention Control Case Management

Trial Details

FieldValue
Enrollment Target 340 participants
Start Date 2009-08
Est. Completion 2014-12
Phase NA
University of South Florida

252 total trials

What the finished NCT02116049 record still lists

NCT02116049 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).

The record links to 0 conditions, and to 2 interventions - of which Disclosure Intervention is the first listed.

NCT02116049 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02116049 about?

NCT02116049 is a clinical study titled "Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners". Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an HIV-positive status may be a ...

What is the current status of trial NCT02116049?

This trial is currently completed. It is a NA study. The enrollment target is 340 participants. The study started on 2009-08. Estimated completion is 2014-12.

What interventions are being tested in trial NCT02116049?

The interventions under investigation include: Disclosure Intervention (BEHAVIORAL), Attention Control Case Management (BEHAVIORAL).

Who is sponsoring clinical trial NCT02116049?

This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02116049's enrollment target sits among peer trials

340 302nd of 2000 higher than 1,696 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02116049, the US trial registry maintained by the National Library of Medicine. NCT02116049 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.