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

NCT03278990 | Terminated

• 1 other identifier: IN-US-276-4221
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention

Keywords

PrEP; Prevention; Value Affirmation; Future Selves; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• PrEP Adherence

  Tenofovir concentrations in dried blood spots

  quarterly, for one year

Secondary Outcomes (4)

• HIV contraction

  quarterly, for one year

• Sexual Risk Behavior 1: Partners

  quarterly, for one year

• Sexual risk behavior 2: Condomless sex

  quarterly, for one year

• STI contraction

  quarterly, for one year

Study Arms (2)

Future Self - Value Affirmation

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Value Affirmation and Future Selves Combination BEHAVIORAL

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.

Future Self - Value Affirmation

Control writing exercise BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Must fit into one of the study's CDC-identified risk strata: a) IDUs and/or b) Caucasian LGBTQ or Minority LGBTQ
• Must be able to read and write English for themselves.

You may not qualify if:

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

Sponsors & Collaborators

• Stuart Fisk: lead
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): collaborator
• Gilead Sciences: collaborator
• University of Pittsburgh: collaborator
• Allies for Health + Wellbeing: collaborator
• Center for Inclusion Health, Allegheny General Hospital: collaborator
• Metro Community Health Center: collaborator

Study Sites (1)

Center for Inclusion Health, Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Study Officials

• Nichole Ben Itzhak, PhD

  BI Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: 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%.

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 12, 2017
• Study Start: December 19, 2018
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)