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Completed

NCT Number: NCT01994603

Expansion to Interdisciplinary HIV Prevention in Women

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.

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Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Alcohol Related Neurodevelopmental Disorder Alcohol-Induced Disorders Alcohol-Related Disorders Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Spectrum Disorders Fetal Alcohol Syndrome Fetal Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pregnancy Complications RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Petersburg State University, Saint Peterburg, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opt-in or Opt-out testing

Behavioral

Study participants will be offered a health screening onsite.

Focus Group

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2013
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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