No label defined (Q31670)

No description defined

Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender women and sexual minority men with a substance use disorder: Assistance Services [...]

Language	Label	Description	Also known as
English	No label defined	No description defined	Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender women and sexual minority men with a substance use disorder: Assistance Services [...]

Statements

instance of

randomized controlled trial

1 reference

stated in

PubMed

title

Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender women and sexual minority men with a substance use disorder: Assistance Services [...] (English)

1 reference

stated in

PubMed

abstract

In the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). (English)

source label

BACKGROUND (English)

subsection NLM category

1

2024

1 reference

Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. (English)

source label

BACKGROUND (English)

subsection NLM category

2

2024

1 reference

Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. (English)

source label

BACKGROUND (English)

subsection NLM category

3

2024

1 reference

SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration. (English)

source label

BACKGROUND (English)

subsection NLM category

4

2024

1 reference

To determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD. (English)

source label

OBJECTIVE (English)

subsection NLM category

5

2024

1 reference

This study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. (English)

source label

METHODS (English)

subsection NLM category

6

2024

1 reference

Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). (English)

source label

METHODS (English)

subsection NLM category

7

2024

1 reference

Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). (English)

source label

METHODS (English)

subsection NLM category

8

2024

1 reference

Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone). (English)

source label

METHODS (English)

subsection NLM category

9

2024

1 reference

Recruitment and enrollment began in May 2023. (English)

source label

RESULTS (English)

subsection NLM category

10

2024

1 reference

Recruitment will span approximately 36 months. (English)

source label

RESULTS (English)

subsection NLM category

11

2024

1 reference

Data collection, including all follow-up assessments, is expected to be completed in April 2027. (English)

source label

RESULTS (English)

subsection NLM category

12

2024

1 reference

Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. (English)

source label

DISCUSSION (English)

subsection NLM category

13

2024

1 reference

To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances. (English)

source label

DISCUSSION (English)

subsection NLM category

14

2024