RH and Adolescents (NCT02713750) | Clinical Trial Compass
CompletedNot Applicable
RH and Adolescents
Thailand77 participantsStarted 2013-03
Plain-language summary
This study will create a model of reproductive health services for HIV-positive female adolescents in Asia.
Who can participate
Age range12 Years – 24 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female 12 to 24 years of age
* HIV-positive status
* HIV-disclosed before screening visit
* Having had first menstrual cycle (menarche)
* Sexually active
* Willing to participate in the study and signed informed consent form, including signed inform consent by caretaker for subjects \<18 years of age
Exclusion Criteria:
* Being pregnant at the time of screening visit
* Mental or physical conditions that may limit informed participation in the study
* Having active AIDS or opportunistic infections
Non-eligible subjects to use hormonal contraception:
* Thrombosis or history of it
* Family history of thrombosis
* Hypertension (for combined oral contraceptives)
* Hyperlipidemia (toxicity grade \>3)
* Diabetes mellitus with vascular involvement
* Presence or history of liver hepatic disease
* Malignant disease of genital organs and breast
* Undiagnosed vaginal bleeding
* Lactation
* Hypersensitivity to steroid hormones
Eligible subjects to use intrauterine device:
* In case of HAART, last CD4 count \> 200 cells/mm3 no more than 6 months prior to the screening
* If without HAART, last CD4 count \>350 cells/mm3 no more than 6 months prior to the screening
* Normal cervical Pap smear in the last 6 months/in the day of IUD insertion
Non-eligible subjects to use intrauterine device:
* Having an active infection of the vagina or cervix
* Having pelvic inflammatory disease (PID) or have a recent history of PID
* Having a bleeding disorder or taking anticoag…
What they're measuring
1
number of participants who use any of the proposed contraceptive methods
Timeframe: 18 months
2
number of participants who adhere to the use of the proposed contraceptive mthods
Timeframe: 18 months
Trial details
NCT IDNCT02713750
SponsorThe HIV Netherlands Australia Thailand Research Collaboration