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Scalable Interventions to Increase PrEP Adherence: Value Affirmation and Future Selves (SIIPA)

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ClinicalTrials.gov Identifier: NCT03278990
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Gilead Sciences
University of Pittsburgh
Allies for Health + Wellbeing
Center for Inclusion Health, Allegheny General Hospital
Metro Community Health Center
Information provided by (Responsible Party):
Stuart Fisk, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief Summary:

Pre-exposure prophylaxis, or PrEP, is a relatively new HIV prevention method where individuals who are at risk for HIV but do not currently have it take a daily pill (Truvada). PrEP has been proven medically effective and could help to reduce the rate of new HIV incidence in the United States, but in five large, randomized and controlled studies, many prospective PrEP patients chose not to take PrEP, and those that did often did not adhere to it consistently. How do we increase PrEP uptake and adherence amongst those most at risk for HIV? Also, will taking PrEP increase or decrease high-risk individual sexual behavior and HIV incidence? Here, the investigators propose a parallel group randomized, controlled clinical trial to test the effectiveness of a behavioral intervention designed to buffer individuals against stigma-related feelings, and to increase their connection to their selves twenty years in the future. The primary objective of the study is to increase PrEP adherence, as measured by the concentration of tenofovir diphosphate (TFV-DP) in dried blood spot samples (DBS). The secondary objectives are to decrease the incidence of STIs and increase safe sexual practices, as measured by clinic diagnoses and self-reported practices at 3, 6, 9 and 12 months.

This 12-month outpatient study will take place at four PrEP clinics in Pittsburgh and will enroll 170 subjects across 4 sites, with an expectation of retaining 80%, or 135 subjects. Eligibility includes male and female adults, ages 18-65, who are at risk of contracting HIV. Efforts will be made to recruit 33% of subjects from each of the following strata: 1) young, minority LGBT adults age 18-30 years of age; 2) Caucasian adults (MSM and heterosexual females) age 18-65 years of age; and 3) IDU adults, age 18-65, of any ethnic background.


Condition or disease Intervention/treatment Phase
HIV Prevention Behavioral: Value Affirmation and Future Selves Combination Behavioral: Control writing exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a parallel group randomized trial with 2 arms—a control arm with allocation ratio of 50%, and an intervention arm (future self-value affirmation) with an allocation ratio of 50%.
Masking: Double (Participant, Care Provider)
Masking Description: Participants are randomly assigned to treatment or control exercises involving writing for 5 minutes. Participants do not know there is another writing condition. Care providers do not see the written content provided by the participant. Neither the participants nor the care provider will know which condition the participant is in.
Primary Purpose: Prevention
Official Title: A Test of Scalable Behavioral Interventions to Increase PrEP Adherence for At-Risk HIV- Individuals: Value Affirmation and Future Selves
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Future Self - Value Affirmation
This is a behavioral intervention whereby participants write (Value Affirmation and Future Selves Combination) for 5 minutes about 1-2 values that are important to them, as well as about a time in their life when they were particularly important. Next, for five minutes, they write a letter to themselves in 20 years.
Behavioral: Value Affirmation and Future Selves Combination
Following the questionnaire, participants will complete a 10- to 15-minute writing exercise. In the control condition, they will be given a list of values, select two that are least important to them, then write about why those values might be important to others. Next, they will write a short letter to themselves in 2 weeks. In the treatment condition, they will be given a list of values, select two that are important to them, then write for about why those values are important to them and how they have played a role in their life. They will then write a short letter to themselves twenty years in the future.

Sham Comparator: Control
In this sham comparator, participants will also write (Control Writing Exercise) --similar to the intervention above. However, the content of the writing exercise is different. Participants write for five minutes about what they did that day. Next, for five minutes, they write a letter to themselves next week.
Behavioral: Control writing exercise
In this sham comparator, participants will also write, however, the content of the writing exercise is different. Participants write for five minutes about what they did that day. Next, for five minutes, they write a letter to themselves next week.




Primary Outcome Measures :
  1. PrEP Adherence [ Time Frame: quarterly, for one year ]
    Tenofovir concentrations in dried blood spots


Secondary Outcome Measures :
  1. HIV contraction [ Time Frame: quarterly, for one year ]
    Diagnosis of HIV throughout the study period

  2. Sexual Risk Behavior 1: Partners [ Time Frame: quarterly, for one year ]
    Number of Partners in anal or vaginal sex

  3. Sexual risk behavior 2: Condomless sex [ Time Frame: quarterly, for one year ]
    number of condomless vaginal or anal sex occurrences

  4. STI contraction [ Time Frame: quarterly, for one year ]
    Diagnosis of an STI throughout the study period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. HIV- men and women, age 18 and higher, who are seeking PrEP and deemed appropriate per local site investigator following the CDC risk indication guidelines for PrEP.
  2. Must fit into one of the study's CDC-identified risk strata: a) IDUs and/or b) Caucasian LGBTQ or Minority LGBTQ
  3. Must be able to read and write English for themselves.

Exclusion Criteria

  1. Same as that for PrEP initiation, e.g., existing HIV+ diagnosis or contra-indications, creatinine GFR < 60.
  2. Current or previous use of PrEP.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278990


Contacts
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Contact: Nichole Ben Itzhak, PhD 917-621-5207 argo.nichole@gmail.com
Contact: Sarah Rutman 412-578-5641 Sarah.RUTMAN@ahn.org

Locations
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United States, Pennsylvania
Center for Inclusion Health, Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Stuart Fisk, RN       stuart.fisk@ahn.org   
Contact: Mary Gallagher       mary.gallagher@ahn.org   
Sponsors and Collaborators
Stuart Fisk
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Gilead Sciences
University of Pittsburgh
Allies for Health + Wellbeing
Center for Inclusion Health, Allegheny General Hospital
Metro Community Health Center
Investigators
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Study Director: Nichole Ben Itzhak, PhD BI Development

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Responsible Party: Stuart Fisk, Sponsor-Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT03278990     History of Changes
Other Study ID Numbers: IN-US-276-4221
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only de-identified information will be shared regarding STI/HIV diagnosis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stuart Fisk, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute):
PrEP
Prevention
Value Affirmation
Future Selves
Behavioral Intervention