Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02447484 |
Other study ID # |
R01DA039071 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2015 |
Est. completion date |
August 2021 |
Study information
Verified date |
September 2021 |
Source |
University of California, San Diego |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine whether a program of regular, theory-based text
messages that encourages the message recipient to continue practicing safer sex (i.e., using
condoms with sex partners) is effective in maintaining positive behavior change in women who
have completed a brief safer-sex training.
Description:
The overarching aim of this study is to evaluate the efficacy of a technology-enabled
behavioral intervention, Mujer Segura Siempre (Healthy Woman Forever: MSS), that is designed
to maintain the effects of a brief, single-session sexual risk reduction intervention (Mujer
Más Segura: MMS) that was proven efficacious in reducing incidence of HIV and sexually
transmitted infections (STIs) among drug- and non-drug-using Mexican female sex workers
(FSWs) in Tijuana and Ciudad Juarez. Despite the efficacy of MMS, it is well known that
treatment effects of health behaviors erode and that adherence to new health behaviors is
often poor, with relapse rates up to 50% or more within 6 months, perhaps because the
constructs responsible for behavior acquisition differ from those that sustain behavior
change. This innovative behavior-maintenance intervention, Mujer Segura Siempre (MSS), will
be delivered using text messaging. It incorporates concepts that are theorized to be
important to sustain positive behavior change, and it builds on maintenance-specific content
and skills that have been significant in interventions focused on other health behaviors
(e.g., smoking cessation, weight loss). All women enrolled in the study will begin by
receiving the Mujer Más Segura (MMS) counseling, with specific information for women who are
intravenous drug users (IDU) in addition to being FSWs. High levels of injection and
non-injection drug use have been reported by FSWs and their male clients in our study sites,
making it imperative to address safer injection practices in both the initial behavior change
program and in our text-based maintenance program.
The text messages that constitute the experimental part of this study will be based on
maintenance-specific behavioral and cognitive constructs that are theorized to be involved in
behavior maintenance, including self-regulatory focus, maintenance self-efficacy, and relapse
prevention planning. The MSS text messaging maintenance intervention will be compared to
time-equivalent exposure to general health text messages. Our specific aims are:
Aim 1: Determine if the MSS intervention (MMS counseling plus 24 months of behavioral
maintenance text messages-Group 1) is associated with significant reductions in HIV/STI
incidence (primary outcome) relative to a time-equivalent control condition (counseling + 24
months of general health text messages-Group 2) among drug-using and non-drug-using FSWs in
Tijuana and Cd. Juarez.
Aim 2: Determine if the MSS intervention is associated with increased use of condoms for
vaginal and anal sex with male clients, better attendance at regularly scheduled STI
screenings, and reduced sharing of injection equipment for FSW-IDU (secondary outcomes)
relative to a time-equivalent control condition.
Aim 3: Determine if substance use factors (frequency, intensity, and patterns of alcohol and
drug use, including injection use, binge use, polydrug use) mediate or moderate intervention
efficacy, taking into account structural and environmental risk factors (e.g., availability
of condoms, drugs in the workplace), maintenance constructs (e.g., relapse prevention
planning, self-efficacy maintenance), and personal characteristics (e.g., age, sexual abuse,
depression).
Aim 4: Evaluate the cost-effectiveness of MSS compared to the control condition, Mujer Más
Segura alone (based on data from previous studies), and usual care in Mexico.
To accomplish these aims, investigators will deliver MSS to 600 HIV-negative FSWs (300 in
Tijuana, 300 in Cd. Juarez) who report unsafe sex with at least one client in the previous 6
months, and randomize them to either one of two groups: Group 1 (n=300), MSS text-based
maintenance program for 24 months post-counseling; or Group 2 (control condition, n=300)
general health text messages for 24 months post counseling. Both groups will be assessed at
6, 12, 18, and 24 months post-counseling.