Expansion to Interdisciplinary HIV Prevention in Women

NCT ID: NCT01994603

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-09-30

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.

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.

Conditions

HIV; AIDS; Fetal Alcohol Syndrome; Alcohol Related Neurodevelopmental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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. "

Group Type: EXPERIMENTAL

Opt-in or Opt-out testing

Intervention Type: BEHAVIORAL

Study participants will be offered a health screening onsite.

Focus Group

Intervention Type: BEHAVIORAL

Study participants will be invited to participate in a focus group discussion.

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.

Group Type: EXPERIMENTAL

Opt-in or Opt-out testing

Intervention Type: BEHAVIORAL

Study participants will be offered a health screening onsite.

Focus Group

Intervention Type: BEHAVIORAL

Study participants will be invited to participate in a focus group discussion.

Interventions

Opt-in or Opt-out testing

Study participants will be offered a health screening onsite.

Intervention Type: BEHAVIORAL

Focus Group

Study participants will be invited to participate in a focus group discussion.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tatiana Balachova

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Alla Shaboltas, PhD

Role: PRINCIPAL_INVESTIGATOR

Saint Petersburg State University, Russia

Locations

University of Oklahoma

Oklahoma City, Oklahoma, United States

St. Petersburg State University

Saint Peterburg, , Russia

Countries

United States; Russia

Other Identifiers

3R01AA016234-05S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1590

Identifier Type: -

Identifier Source: org_study_id