Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-03 @ 8:15 PM
Study NCT ID:
NCT02713750
Status:
COMPLETED
Last Update Posted:
2016-03-21
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RH and Adolescents
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
Study Overview
Official Title:
Optimization of Reproductive Health Care for Female Adolescents Living With HIV (Reproductive Health in HIV-infected Female Adolescents)
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: