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Active Clinical Trials

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

Active NCT:
03278990
Federal North Building
Federal North Building

Sponsor: 
Nichole Ben Itzhak
Contact: 

For more information, please contact Debra Tilves by telephone at 412-359-8386 or email at Debra.Tilves@ahn.org .

A Test of Scalable Behavioral Interventions to Increase PrEP Adherence: Value Affirmation and the Future Self

Purpose: 

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.

Ages Eligible for Study:  18 Years to 65 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  Yes

Inclusion Criteria:

HIV- males and females, age 18 to 65 years, who are at risk of contracting HIV.

Risk indication includes:

A) Men who have sex with men (MSM) who have recently (defined as previous 6 months by US Public Health Services): i. reported high-risk sexual behaviors (unprotected anal sex) with persons who are known to be HIV positive or unknown HIV status ii. had documented STI (more than one anogenital in one year) iii. been prescribed non-occupational post-exposure prophylaxis (nPEP) with continued high risk iv. used transactional sex or stimulant drugs associated with high-risk sexual behaviors v. been in a relationship with HIV positive male partner B) Heterosexually active men or women who infrequently use condoms and have sex with partners who are at high risk for HIV-infection (injection drug users, MSM or bisexual, those from areas of high HIV prevalence), use transactional sex, or have ongoing relationship with HIV positive partner.

C) Injection drug users who, within the last six months, have shared needles/equipment or have initiated substance abuse treatment within the last 6 months (high risk for relapse).

Must be able to read and understand English and consent for themselves.

Documented negative HIV test within one week prior to initiation of PrEP medication. Must be 4th generation HIV Ag/Ab combination test. Oral rapid test is not accepted.

Exclusion Criteria:

Same as that for PrEP initiation: HIV+ diagnosis, not medically eligible for PrEP use because of contra-indications.

Already using PrEP