NCT03278990: SIIPA

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

Terminated NA Last updated 11 October 2021

What this trial tests

NA trial testing Value Affirmation and Future Selves Combination in HIV Prevention in 26 participants. Terminated before completion.

Timeline

19 December 2018

Primary endpoint
16 December 2020

16 December 2020

Quick facts

Lead sponsor	Stuart Fisk
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	26
Start date	19 December 2018
Primary completion	16 December 2020
Estimated completion	16 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Value Affirmation and Future Selves Combination
• Control writing exercise

Conditions studied

• HIV Prevention — all drugs for HIV Prevention →

Sponsor

Stuart Fisk

Who can join

Adults 18 to 65, any sex, with HIV Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.