Clinical trial NCT02713750: RH and Adolescents
Official title: Optimization of Reproductive Health Care for Female Adolescents Living With HIV (Reproductive Health in HIV-infected Female Adolescents)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproductive Health
Keywords: Combined Oral Contraceptives
Highly Active Antiretroviral Therapy
Hormonal Contraception
Human Immunodeficiency Virus
Intrauterine Device
Pharmacokinetic
Sexually Transmitted Diseases
Reproductive Health
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: amfAR, The Foundation for AIDS Research
name: ViiV Healthcare
First posted: 2016-03-21
Enrollment: 77
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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.

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

Eligibility criteria: 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 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

Primary outcomes:
measure: number of participants who use any of the proposed contraceptive methods
timeFrame: 18 months
measure: number of participants who adhere to the use of the proposed contraceptive mthods
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT, Thai Red Cross AIDS Research Centre
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital of The Royal Thai Army
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
city: Petchaburi
country: Thailand
facility: Phachomklao Hospital
Study officials:
References:
citation: 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.