Determining Characteristics and Behaviors of Adolescent Women Regarding HIV Risk and Microbicide Trial Participation
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This study will examine characteristics and behaviors of young women in India and Tanzania to
      determine which challenges and opportunities exist for conducting future trials of HIV
      prevention treatments.
    

Detailed description: 
      HIV is an infection that damages a person's immune system and can develop into AIDS. More
      than 10 million women between the ages of 15 and 24 currently live with HIV or AIDS, most of
      them in sub-Saharan Africa and Asia. The rate of infections in women is high in part because
      they may not be able to use existing HIV prevention methods: remaining abstinent does not
      help if their partner is not also abstinent and using a male condom requires the compliance
      of the male. Oral and topical microbicides are products women initiate using to reduce their
      risk of HIV infection. Several clinical trials of these products have been conducted, but few
      have tested populations of young women, who may have different characteristics or behaviors
      from other women. This study will collect data on the characteristics and behaviors of women
      divided into two age groups, women age 15 to 17 and women age 18 to 21, in both Tanzania and
      India. This study will have four goals: (1) to determine whether and how characteristics that
      put women at risk for HIV differ in these age and country groups; (2) to evaluate the legal,
      social, cultural, and delivery factors that hinder women's participation in microbicide
      trials; (3) to examine the understanding and ability of women in these different groups to
      adhere to the requirements of clinical trial participation; and (4) to determine young
      women's acceptability and use of a practice gel or pill.

      This study will consist of three phases. The first phase will address the first two goals by
      conducting repeated, in-depth interviews and discussions with a small group of sexually
      active adolescents in India and Tanzania, followed up by interviews with informants and
      relevant community members. These interviews and discussions will address differences in HIV
      risk characteristics between groups of women and the legal, social, cultural, and delivery
      factors hindering women's participation in microbicide trials. The second phase will consist
      of a series of workshops to define and describe a set of youth-friendly procedures for using
      microbicides. Community members and researchers will participate in these workshops, and some
      adolescents will be invited to pretest the study instruments.

      The third phase will be a pilot clinical study that addresses the second two goals by asking
      participants to undergo evaluations over time, similar to the way they would have to in a
      microbicide trial. Participants will complete study visits at baseline and after 2, 4, and 6
      months, during which time they will answer questions about their sexual relationships and use
      of risk reduction behaviors. They will also provide urine, blood, and endo-cervical swab
      samples for testing for pregnancy, HIV, and sexually transmitted infection. Between the 4-
      and 6-month visits, participants will also be asked to participate in a 2-month substudy in
      which they use proxy pills or gels. They will then complete interviews about their
      experiences using the pills or gels. Some participants who decline to participate will be
      invited to complete brief interviews about why they chose not to participate.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Formative research will recruit adolescents and other participants from community samples
        in Pune, India and Dar es Salaam, Tanzania.

        Pilot clinical study will recruit adolescents from India and Tanzania through healthcare
        facilities, nongovernmental organizations, and other mechanisms.
      
Keywords: Clinical Trials as Topic; Adolescent Psychology; Patient Acceptance of Health Care; HIV Risk Behaviors; Adolescents; Clinical Trial Recruitment; Microbicide Acceptability; Ethics; Mixed Methods; HIV