RH and Adolescents
Condition: Reproductive Health
Study type: Observational

Summary: 
      This study will create a model of reproductive health services for HIV-positive female
      adolescents in Asia.
    

Detailed description: 
      For the implementation of risk reduction interventions, it is equally important to provide
      specific knowledge and continuous counseling on different preventive options. A perfect
      preventive method, which provides highly reliable dual protection both from unintended
      pregnancies and from HIV/STDs with no side effects and which is completely accepted, is not
      available. Many authors consider that the most effective way to achieve dual protection is
      the simultaneous use of two contraceptive methods, one of which is a barrier method such as
      the male or female condom, and the other a highly effective contraceptive method, such as
      hormonal contraception (HC), intrauterine device (IUD) or sterilization. This is called dual
      contraception. Therefore this project will focus on specific reproductive service delivery
      for these groups of patients. As the age group is very young, the investigators will use in
      the study only reversible highly effective methods of contraception - HC, combined or
      progestin only, and an IUD - and condoms. For example, HC for HIV-positive women has been
      studied extensively in the last two decades, yet there are still no definitive answers
      regarding key issues - HIV disease progression, genital tract HIV shedding and infectivity,
      pharmacokinetic (PK) interactions between hormones and ARVs, and therefore a possibility for
      compromise of contraceptive effect and/or ARV failure, and last but not least, metabolic
      outcomes. Data on the effect of hormonal contraception on HIV disease progression is still
      inconclusive. Unfortunately there is only a limited number of studies in this field, with
      very small sample sizes and in most cases outside "real life" conditions.

      There are three substudies:

        1. Pharmacokinetic interactions between the sex steroid hormones and the protease
           inhibitors in HIV-positive Thai female adolescents

        2. Assessment of premenstrual syndrome in HIV-positive adolescents

        3. Metabolic changes in HIV + female adolescents on ART with hormonal contraception
    

Intervention name(s): reversible contraceptive methods
Intervention type(s): Other
Intervention description(s): Consistent male condom use only
Consistent female condom use only
Hormonal contraception, combined oral contraceptive pills and male/female condom
Hormonal contraception, progestin only depot medroxyprogesterone acetate (DMPA) injectable and male/female condom
Hormonal contraception , progestin only hormonal implant and male/female condom
Intrauterine device and male/female condom
Intervention MeSH terms: Contraceptive Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 sexually active, HIV-infected female adolescents, 12-24 years old. All subjects should
        know their HIV status.
      
Biospecimen description: 
      Blood
    
Keywords: Combined Oral Contraceptives; Highly Active Antiretroviral Therapy; Hormonal Contraception; Human Immunodeficiency Virus; Intrauterine Device; Pharmacokinetic; Sexually Transmitted Diseases; Reproductive Health