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NCT01632397 · ClinicalTrials.gov registry record · Phase 4

Pre-exposure Prophylaxis Adherence Intervention for MSM

A Phase 4 study of Medication Adherence, sponsored by Fenway Community Health.

Completed
Registry status
Phase 4
Development phase
103
Enrollment target
1
Study location

NCT01632397 is a Phase 4 study of Medication Adherence that has completed, run by Fenway Community Health. The registered enrollment target is 103 participants, below the 1,655-participant average among 52 other Medication Adherence trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01632397, a Phase 4 study of Medication Adherence, has completed, sponsored by Fenway Community Health.

COMPLETED
Registry status
Phase 4
Development phase
103 participants
Enrollment target
1
Study location

Study Summary

Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.

Conditions Studied

Interventions

  • BEHAVIORAL CBT-based counseling
  • BEHAVIORAL Health education and supportive counseling

Study Locations (1)

Massachusetts

  • The Fenway Institute - Boston

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2011-08
Est. Completion 2014-02
Phase Phase 4

Sponsor

Fenway Community Health

14 total trials

What the Registry Record Tells You About NCT01632397

The ClinicalTrials.gov registry entry for NCT01632397 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,655-participant average among 52 other Medication Adherence trials with a reported enrollment target (94% lower). The listed sponsor is Fenway Community Health, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Medication Adherence appearing as the primary indexed condition, and to 2 interventions - of which CBT-based counseling is the first listed.

NCT01632397 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01632397 about?

NCT01632397 is a clinical study titled "Pre-exposure Prophylaxis Adherence Intervention for MSM". Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.

What is the current status of trial NCT01632397?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 103 participants. The study started on 2011-08. Estimated completion is 2014-02.

What conditions does trial NCT01632397 study?

This clinical trial studies the following conditions: Medication Adherence.

What interventions are being tested in trial NCT01632397?

The interventions under investigation include: CBT-based counseling (BEHAVIORAL), Health education and supportive counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT01632397?

This trial is sponsored by Fenway Community Health, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01632397 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.