Texting Intervention to Sustain HIV Prevention in Women in High-drug-use Contexts

NCT02447484 | Completed DMC

• 1 other identifier: R01DA039071
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Syphilis; Gonorrhea; Chlamydia

Keywords

female sex workers; HIV sexual risk reduction; behavior maintenance; text messaging

Outcome Measures

Primary Outcomes (1)

• HIV and STI incidence

  24 months

Secondary Outcomes (3)

• Condom use

  24 months

• Attendance at regularly scheduled STI screenings

  24 months

• Sharing of injection equipment

  24 months

Study Arms (2)

Mujer Segura Siempre

EXPERIMENTAL

Twice-daily safer-sex and safer-drug-use text messages, 5 days per week, for 24 months. Text message content based on 8 different constructs of behavior-maintenance theory and tailored to specific preferences and motivators provided by participant.

Behavioral: Mujer Segura Siempre

General Health Message Texts

ACTIVE COMPARATOR

Twice-daily text messages, 5 days per week, for 24 months. Text message content centered on general health promotion, including getting regular medical checkups and maintaining good dietary and exercise habits.

Behavioral: General Health Message Texts

Interventions

Mujer Segura Siempre BEHAVIORAL

Participants receive personalized text messages twice a day, five days per week. Messages are designed to encourage women to maintain positive behavioral changes they have made in response to the baseline safer-sex training that is delivered to all participants regardless of intervention assignment. Message content is based upon theoretical constructs of behavior-change maintenance as articulated by Voils et al. (Health Education \& Behavior, 2013). Personalization elements include participant's name, times of day when she prefers to receive messages, and specific motivators of behavior change she expressed in the baseline interview.

Mujer Segura Siempre

General Health Message Texts BEHAVIORAL

Participants receive generic health-promotion text messages twice a day, five days per week.

General Health Message Texts

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biologically female,
• at least 18 years old,
• report having exchanged sex for money, goods, shelter or drugs within the previous 30 days,
• test HIV-negative at baseline,
• agreeable to receiving antibiotic treatment for chlamydia, gonorrhea, syphilis and trichomoniasis if they test positive (to allow us to differentiate incident from prevalent cases at follow-up),
• report having unprotected vaginal or anal sex with a male client at least once during the previous month, and
• be treatment-naive (i.e., must not have already participated in the Mujer Segura or Mujer Más Segura safer-sex interventions).

You may not qualify if:

• Consistent use of condoms for vaginal and anal sex with all male clients during the previous month,
• known to be HIV+ or test HIV+ for the first time on-site,
• under 18 years of age,
• male or transgendered, and
• incapable of giving informed consent.

Sponsors & Collaborators

• University of California, San Diego: lead
• Comisión de Salud Fronteriza México-Estados Unidos (CSFMEU): collaborator

Study Sites (1)

PreveCasita

Tijuana, Estado de Baja California, Mexico

Location

Related Publications (2)

• Patterson TL, Pitpitan EV, Pines HA, Semple SJ, Harvey-Vera A, Depp C, Moore DJ, Martinez G, Rangel MG, Strathdee SA. A Randomized Controlled Trial of a Texting Intervention to Maintain Sexual Risk Reduction with Clients Among Female Sex Workers in Tijuana and Ciudad Juarez, Mexico. AIDS Behav. 2020 Dec;24(12):3306-3319. doi: 10.1007/s10461-020-02930-1.

  PMID: 32444901 DERIVED

• Pines HA, Semple SJ, Strathdee SA, Hendrix CW, Harvey-Vera A, Gorbach PM, Magis-Rodriguez C, Martinez G, Patterson TL. Vaginal washing and lubrication among female sex workers in the Mexico-US border region: implications for the development of vaginal PrEP for HIV prevention. BMC Public Health. 2018 Aug 14;18(1):1009. doi: 10.1186/s12889-018-5946-z.

  PMID: 30107833 DERIVED

MeSH Terms

Conditions

Syphilis; Gonorrhea; Chlamydia Infections

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; Chlamydiaceae Infections

Study Officials

• Thomas L Patterson, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 18, 2015
• Study Start: July 1, 2015
• Primary Completion: April 30, 2021
• Study Completion: August 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

ME (1)