Reproductive HealthNCT02713750
RH and Adolescents
An observational study of Reproductive Health, run by The HIV Netherlands Australia Thailand Research Collaboration at 4 sites in Thailand.
Trial summary
This study will create a model of reproductive health services for HIV-positive female adolescents in Asia. Read more about this study
- Who is it for?
- Ages 12 to 24 years, women only
- Conditions the study is for
- Reproductive Health
- What is being tested?
- reversible contraceptive methods
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 77 participants
- Where
- 4 sitesThailand
- Study dates
- Mar 2013to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 100 sexually active, HIV-infected female adolescents, 12-24 years old. All subjects should know their HIV status.
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, 10330
Phramongkutklao Hospital of The Royal Thai Army
Bangkok
Srinagarind Hospital, Khon Kaen University
Khon Kaen
Phachomklao Hospital
Phetchaburi
About this study
Official title: Optimization of Reproductive Health Care for Female Adolescents Living With HIV (Reproductive Health in HIV-infected Female Adolescents)
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:
- Pharmacokinetic interactions between the sex steroid hormones and the protease inhibitors in HIV-positive Thai female adolescents
- Assessment of premenstrual syndrome in HIV-positive adolescents
- Metabolic changes in HIV + female adolescents on ART with hormonal contraception
- Conditions
- Reproductive Health
- Being tested
- reversible contraceptive methods
- Keywords
- Combined Oral Contraceptives, Highly Active Antiretroviral Therapy, Hormonal Contraception, Human Immunodeficiency Virus, Intrauterine Device, Pharmacokinetic, Sexually Transmitted Diseases, Reproductive Health
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reversible contraceptive methodsOther
- Consistent male condom use only
- Consistent female condom use only
- Hormonal contraception, combined oral contraceptive pills and male/female condom
- Hormonal contraception, progestin only depot medroxyprogesterone acetate (DMPA) injectable and male/female condom
- Hormonal contraception , progestin only hormonal implant and male/female condom
- Intrauterine device and male/female condom
| Study group | Role | What they receive |
|---|---|---|
| HIV female adolescents | sexually active, HIV-infected female adolescents, 12-24 years old who are aware of their HIV status Receives: Other: reversible contraceptive methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants who use any of the proposed contraceptive methods
Measured: 18 months
number of participants who adhere to the use of the proposed contraceptive mthods
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research, ViiV Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713750
- Sponsor's protocol ID
- HIV-NAT 176
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Reproductive Health Care for Female Adolescents Living With HIV (Reproductive Health in HIV-infected Female Adolescents)
- ClinicalTrials.gov ID
- NCT02713750
- Acronym / sponsor ID
- HIV-NAT 176
- Conditions
- Reproductive Health
- Keywords
- Combined Oral Contraceptives, Highly Active Antiretroviral Therapy, Hormonal Contraception, Human Immunodeficiency Virus, Intrauterine Device, Pharmacokinetic, Sexually Transmitted Diseases, Reproductive Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research, ViiV Healthcare
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pharmacokinetic interactions between the sex steroid hormones and the protease inhibitors in HIV-positive Thai female adolescents
- Assessment of premenstrual syndrome in HIV-positive adolescents
- Metabolic changes in HIV + female adolescents on ART with hormonal contraception
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV female adolescents | – | Other: reversible contraceptive methodssexually active, HIV-infected female adolescents, 12-24 years old who are aware of their HIV status |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 100 sexually active, HIV-infected female adolescents, 12-24 years old. All subjects should know their HIV status.
Key inclusion criteria (6 listed)
- Female 12 to 24 years of age
- HIV-positive status
- HIV-disclosed before screening visit
- Having had first menstrual cycle (menarche)
- Sexually active
Key exclusion criteria (26 listed)
- 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
- Thrombosis or history of it
- Family history of thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reversible contraceptive methods1. 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 | Other | HIV female adolescents |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Results publication: PubMed 26181814Kancheva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Health, run by The HIV Netherlands Australia Thailand Research Collaboration at 4 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants who use any of the proposed contraceptive methods (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02713750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.