NCT02713750

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

2.7 years

First QC Date

March 9, 2016

Last Update Submit

March 15, 2016

Conditions

Reproductive Health

Keywords

Combined Oral ContraceptivesHighly Active Antiretroviral TherapyHormonal ContraceptionHuman Immunodeficiency VirusIntrauterine DevicePharmacokineticSexually Transmitted DiseasesReproductive Health

Outcome Measures

Primary Outcomes (2)

  • number of participants who use any of the proposed contraceptive methods

    18 months

  • number of participants who adhere to the use of the proposed contraceptive mthods

    18 months

Study Arms (1)

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

reversible contraceptive methodsOTHER

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

HIV female adolescents

Eligibility Criteria

Age12 Years - 24 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

100 sexually active, HIV-infected female adolescents, 12-24 years old. All subjects should know their HIV status.

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Phramongkutklao Hospital of The Royal Thai Army

Bangkok, Thailand

Location

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Thailand

Location

Phachomklao Hospital

Phetchaburi, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 26181814RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 21, 2016

Study Start

March 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

TH(4)