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

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

Interventions

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.

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.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  collaborator OTHER

• Gilead Sciences

  collaborator INDUSTRY

• University of Pittsburgh

  collaborator OTHER

• Allies for Health + Wellbeing

  collaborator UNKNOWN

• Center for Inclusion Health, Allegheny General Hospital

  collaborator UNKNOWN

• Metro Community Health Center

  collaborator UNKNOWN

• Stuart Fisk

  lead OTHER

Principal Investigators

• Nichole Ben Itzhak, PhD · BI Development

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-12-19

Primary Completion

2020-12-16

Completion

2020-12-16

Countries

• United States

Study Locations