An observational study in Reproductive Health, sponsored by The HIV Netherlands Australia Thailand Research Collaboration. Completed at 4 sites in Thailand. Open to female participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2016-03-21.
Sponsored by The HIV Netherlands Australia Thailand Research Collaboration · Observational
This study will create a model of reproductive health services for HIV-positive female adolescents in Asia.
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:
The HIV Netherlands Australia Thailand Research Collaboration is the lead sponsor of 59 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
100 sexually active, HIV-infected female adolescents, 12-24 years old. All subjects should know their HIV status.
Exclusion Criteria:
Non-eligible subjects to use hormonal contraception:
Eligible subjects to use intrauterine device:
Non-eligible subjects to use intrauterine device:
sexually active, HIV-infected female adolescents, 12-24 years old who are aware of their HIV status
Other: reversible contraceptive methods
1. Consistent male condom use only 2. Consistent female condom use only 3. Hormonal contraception, combined oral contraceptive pills and male/female condom 4. Hormonal contraception, progestin only depot medroxyprogesterone acetate (DMPA) injectable and male/female condom 5. Hormonal contraception , progestin only hormonal implant and male/female condom 6. Intrauterine device and male/female condom
number of participants who use any of the proposed contraceptive methods
Time frame: 18 months
number of participants who adhere to the use of the proposed contraceptive mthods
Time frame: 18 months
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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The HIV Netherlands Australia Thailand Research Collaboration