CClinicalTrials.gg
CompletedNCT02713750Updated Mar 21, 2016

RH and Adolescents

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
77
Ages
12 Years to 24 Years
Sex
Female
01

Study summary

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

Read the 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
02

Conditions studied

  • Reproductive Health

Keywords

  • Combined Oral Contraceptives
  • Highly Active Antiretroviral Therapy
  • Hormonal Contraception
  • Human Immunodeficiency Virus
  • Intrauterine Device
  • Pharmacokinetic
  • Sexually Transmitted Diseases
  • Reproductive Health
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
12 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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 anticoagulants
  • Having abnormalities of the uterus
  • Having a uterine infection after childbirth or a septic abortion
  • Having uterine bleeding of unknown origin
  • Having an allergy to copper
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
77 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • HIV female adolescents

    sexually active, HIV-infected female adolescents, 12-24 years old who are aware of their HIV status

    Other: reversible contraceptive methods

Interventions

  • Otherreversible 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

06

What researchers measure

Primary outcomes

  1. number of participants who use any of the proposed contraceptive methods

    Time frame: 18 months

  2. number of participants who adhere to the use of the proposed contraceptive mthods

    Time frame: 18 months

07

Study locations

4 sites
  • HIV-NAT, Thai Red Cross AIDS Research Centre
    Bangkok, 10330, Thailand
  • Phramongkutklao Hospital of The Royal Thai Army
    Bangkok, Thailand
  • Srinagarind Hospital, Khon Kaen University
    Khon Kaen, Thailand
  • Phachomklao Hospital
    Petchaburi, Thailand
08

References and documents

Publications

  • Kancheva Landolt N, Bunupuradah T, Achalapong J, Kosalaraksa P, Petdachai W, Ngampiyaskul C, Auchieng C, Ananworanich J, Boonyanurak P. Premenstrual Disorders Among Perinatally HIV-Infected Adolescents. J Acquir Immune Defic Syndr. 2015 Dec 1;70(4):e150-3. doi: 10.1097/QAI.0000000000000762. No abstract available. PubMed 26181814 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02713750
Lead sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
amfAR, The Foundation for AIDS Research, ViiV Healthcare
Responsible party
Sponsor
First posted
Mar 21, 2016
Start date
Mar 2013
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Mar 21, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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