Expansion to Interdisciplinary HIV Prevention in Women

• ClinicalTrials.gov Identifier: NCT01994603
• Recruitment Status: Completed
• First Posted: November 26, 2013
• Last Update Posted: January 14, 2016
• Sponsor: University of Oklahoma
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): University of Oklahoma

Study Description

Brief Summary:

This trial will pilot test intervention strategies to increase utilization of HIV testing and gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV sexual transmission in the general population in Russia. The study will assess whether external (cost, convenience) or internal factors (low perception of own risk, reluctance to identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested and if peer support impacts their decision. A randomized experimental manipulation, comparing opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed by a second-chance testing offer will be used to inform these questions. The answers will enable the international research team to engineer and then test an HIV testing promotion strategy in Russia. The project will collect preliminary data for a larger study to develop an evidence-based program to reduce the HIV transmission in this high risk population.

Condition or disease	Intervention/treatment	Phase
HIV; AIDS; Fetal Alcohol Syndrome; Alcohol Related Neurodevelopmental Disorder	Behavioral: Opt-in or Opt-out testing; Behavioral: Focus Group	Not Applicable

Detailed Description:

A mixed methods research design combining qualitative and quantitative data collection methods will be used to increase the understanding of barriers to HIV testing, identify promising strategies to increase testing, generate research hypotheses, and design a future randomized clinical trial to evaluate HIV prevention targeted to at-risk women in the general population in Russia. The qualitative methods include structured interviews and a focus group participation to assess women's reasons for being the tested and possible prevention strategies. The quantitative methods include observation/recording of women's testing behaviors.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women
• Study Start Date: December 2012
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Opt-in testing; Participants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group. Opt-in: Common barriers to HIV screening testing will be removed as much as possible (i.e., providing rapid testing, results shortly available, testing on-site, confidentiality). "There is voluntary HIV testing available to all study participants if you wish to do it. "	Behavioral: Opt-in or Opt-out testing; Study participants will be offered a health screening onsite.; Behavioral: Focus Group; Study participants will be invited to participate in a focus group discussion.
Experimental: Opt-out testing; Participants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group. Opt-out multicomponent testing. Participants will be informed that a bundled routine health test is available on a voluntary basis to study participants, and the participant may elect to decline all or part of the testing.	Behavioral: Opt-in or Opt-out testing; Study participants will be offered a health screening onsite.; Behavioral: Focus Group; Study participants will be invited to participate in a focus group discussion.

Outcome Measures

Primary Outcome Measures :

1. Number of participants who completed HIV test [ Time Frame: First 1: at initial contact, an expected average of 15 minutes ]
   A brief survey completed over the phone. Participants asked when the last HIV test was completed and her reasons for taking the test.
2. Number of participants who accepted a rapid health screening/HIV test [ Time Frame: Phase 2: an expected average of 2 hours ]
   Women's decision to take/not take a health screening test/HIV test is recorded. If a woman chooses to be tested, she will be asked a few questions to assess her reasons for being tested. She will be provided with the results of the testing. If a woman's test is positive for HIV (or other health risks in the bundled opt-out condition), counseling with a trained study nurse, physician or psychologist will be available on-site and a referral for additional testing, counseling, and appropriate medical care will be provided.

Secondary Outcome Measures :

1. Brief survey to assess reasons for being tested [ Time Frame: Phase 2: at time of completing HIV testing ]
   Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 44 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• A parent study participants who completed HIV risk survey and
• Reported two or more partners in the last 12 months and no or inconsistent condom use in the last 3 months and no HIV testing in the last 12 months
• Or reported any sexually-transmitted disease and no HIV testing in the last 12 months

Exclusion Criteria:

• A parent study participants who declined to be contacted for participating in future research studies

Contacts and Locations

Locations

United States, Oklahoma

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Russian Federation

St. Petersburg State University

St. Peterburg, Russian Federation, 199034

Sponsors and Collaborators

University of Oklahoma

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Tatiana Balachova; University of Oklahoma
• Principal Investigator: Alla Shaboltas, PhD; Saint Petersburg State University, Russia

More Information

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT01994603 History of Changes
• Other Study ID Numbers: 1590; 3R01AA016234-05S1 ( U.S. NIH Grant/Contract )
• First Posted: November 26, 2013
• Last Update Posted: January 14, 2016
• Last Verified: January 2016

Keywords provided by University of Oklahoma:

Prevention; HIV; AIDS; Fetal Alcohol Syndrome (FAS); Alcohol Related Neurodevelopmental Disorder (ARND)

Additional relevant MeSH terms:

Fetal Alcohol Spectrum Disorders; Neurodevelopmental Disorders; Mental Disorders; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders