The Evidence for Contraceptive Options and HIV Outcomes Trial
NCT ID: NCT02550067
Last Updated: 2019-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7830 participants
INTERVENTIONAL
2015-12-14
2018-10-31
Brief Summary
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Detailed Description
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Enrollment will require an estimated 18 months and the total duration of the clinical portion of the study is estimated to be 36 months.
The primary objective is to compare the risks of HIV acquisition between women randomized to DMPA, levonorgestrel (LNG) implant, and copper IUDs. Secondary objectives are to compare: 1) pregnancy rates among women randomized to DMPA, LNG implant, and copper IUDs, 2) rates of serious adverse events among women randomized to DMPA, LNG implant, and copper IUDs, 3) rates of adverse events that lead to method discontinuation among women randomized to DMPA, LNG implant, and copper IUDs, and 4) contraceptive method continuation rates among women randomized to DMPA, LNG implant, and copper IUDs. Tertiary objectives are to evaluate: 1) whether age modifies the relationship between the three contraceptive methods and HIV acquisition, 2) whether HSV-2 status modifies the relationship between the three contraceptive methods and HIV acquisition, and 3) early HIV disease progression among sero-converters randomized to DMPA, LNG implant, and copper IUDs. Ancillary studies will assess biological mechanisms at the interface of contraceptives and markers of HIV risk.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Depot medroxyprogesterone acetate (DMPA)
Women randomized to DMPA, will receive an intramuscular injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL) at enrolment. Subsequent injections will be given every 3 months (i.e., at quarterly study visits) at the study site.
DMPA
Women randomized to DMPA, will receive an intramuscular injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL) at enrolment. Subsequent injections will be given every 3 months (i.e., at quarterly study visits) at the study site.
Levonorgestrel implant (LNG)
Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
LNG
Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
Copper T380a IUD
Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.
Copper IUD
Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.
Interventions
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DMPA
Women randomized to DMPA, will receive an intramuscular injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL) at enrolment. Subsequent injections will be given every 3 months (i.e., at quarterly study visits) at the study site.
LNG
Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
Copper IUD
Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HIV-seronegative
* Wants to use effective contraception
* Is able and willing to provide written informed consent
* Agrees to be randomized to either DMPA, LNG implant, or copper IUD
* Agrees to use assigned method for 18 months
* Agrees to follow all study requirements
* Intends to stay in the study area for the next 18 months, and willing and able to provide adequate locator information
* If has had a recent third trimester birth, is at least 6 weeks postpartum
* Is sexually active (has had vaginal sex within the last 3 months) or was pregnant within the last 3 months
* Agrees not to participate in studies of drugs or vaccines or any other clinical research study while participating in this study.
Exclusion Criteria
* Is found to have pelvic tuberculosis or uterine fibroids with distortion of the uterine cavity on pelvic exam
* Has untreated mucus and purulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhea or chlamydia
* Has received a DMPA or NET-En injection in the last 6 months
* Has used an implant or an IUD in the last 6 months
* Is pregnant or intending to become pregnant in the next 18 months
* Has had a hysterectomy or sterilization
* Has previously participated in the study
* Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation.
16 Years
35 Years
FEMALE
Yes
Sponsors
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University of Washington
OTHER
Wits Reproductive Health and HIV Institute
OTHER
World Health Organization
OTHER
Madibeng Centre for Research
OTHER
Maternal Adolescent and Child Health Research
UNKNOWN
Qhakaza Mbokodo Research Clinic
UNKNOWN
The Aurum Institute NPC
OTHER
Effective Care Research Unit
OTHER
Emavundleni Research Centre
UNKNOWN
Setshaba Research Centre
UNKNOWN
University of North Carolina, Chapel Hill
OTHER
Family Life Association of Swaziland
UNKNOWN
ICAP Columbia University
UNKNOWN
Kenya Medical Research Institute
OTHER
FHI 360
OTHER
Responsible Party
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Locations
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FLAS/ICAP Clinic 1& Clinic 2
Manzini, , Eswatini
Kisumu East Research Care and Training Program
Kisumu, , Kenya
Madibeng Centre for Research
Brits, , South Africa
Emavundleni Research Centre
Cape Town, , South Africa
MatCH Research Unit Commercial City
Durban, , South Africa
Effective Care Research Unit (ECRU) Frere Maternity Hospital
East London, , South Africa
Wits Reproductive Health and HIV Institute (WRHI)
Johannesburg, , South Africa
Aurum Klerksdorp Gavin Churchyard Legacy Centre
Klerksdorp, , South Africa
QM ladysmith
Ladysmith, , South Africa
MatCH Research Unit Edendale
Pietermaritzburg, , South Africa
Setshaba Research Centre
Soshanguve, , South Africa
University Teaching Hospital, Lusaka, Zambia
Lusaka, , Zambia
Countries
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References
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Morrison S, Batting J, Wanga V, Beesham I, Deese J, Hofmeyr GJ, Kasaro MP, Louw C, Morrison C, Mugo NR, Palanee-Phillips T, Pleaner M, Reddy K, Scoville CW, Smit J, Stringer JSA, Ahmed K, Bukusi E, Kotze P, Baeten JM; ECHO Trial Team. True and False Positive HIV Point of Care Test Results in a Prospective Multinational Study of At-Risk African Women: Implications for Large-Scale Repeat HIV Testing in HIV Prevention Programs. J Acquir Immune Defic Syndr. 2024 Dec 1;97(4):364-370. doi: 10.1097/QAI.0000000000003497.
Hofmeyr GJ, Singata-Madliki M, Batting J, Balakrishna Y, Morroni C. Effects of depot medroxyprogesterone acetate, the copper IUD and the levonorgestrel implant on testosterone, sex hormone binding globulin and free testosterone levels: ancillary study of the ECHO randomized clinical trial. BMC Womens Health. 2024 Mar 8;24(1):167. doi: 10.1186/s12905-024-02990-8.
Beesham I, Mansoor LE, Joseph Davey DL, Palanee-Phillips T, Smit J, Ahmed K, Selepe P, Louw C, Singata-Madliki M, Kotze P, Heffron R, Parikh UM, Wiesner L, Rees H, Baeten JM, Beksinska M. Brief Report: Quantifiable Plasma Tenofovir Among South African Women Using Daily Oral Pre-exposure Prophylaxis During the ECHO Trial. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):26-30. doi: 10.1097/QAI.0000000000003023. Epub 2022 Jun 9.
Bunjun R, Ramla TF, Jaumdally SZ, Noel-Romas L, Ayele H, Brown BP, Gamieldien H, Harryparsad R, Dabee S, Nair G, Onono M, Palanee-Phillips T, Scoville CW, Heller KB, Baeten JM, Bosinger SE, Burgener A, Passmore JS, Jaspan H, Heffron R. Initiating Intramuscular Depot Medroxyprogesterone Acetate Increases Frequencies of Th17-like Human Immunodeficiency Virus Target Cells in the Genital Tract of Women in South Africa: A Randomized Trial. Clin Infect Dis. 2022 Nov 30;75(11):2000-2011. doi: 10.1093/cid/ciac284.
Ryan R, Mussa A, Singtaa-Madliki M, Batting J, Balakrishna Y, Morroni C, Hofmeyr GJ. Effects of Depot Medroxyprogesterone Acetate Intramuscular Injection, Copper Intrauterine Device and Levonorgestrel Implant Contraception on Estradiol Levels: An Ancillary Study of the ECHO Randomized Trial. Front Glob Womens Health. 2022 May 20;3:887541. doi: 10.3389/fgwh.2022.887541. eCollection 2022.
Palanee-Phillips T, Rees HV, Heller KB, Ahmed K, Batting J, Beesham I, Heffron R, Justman J, Makkan H, Mastro TD, Morrison SA, Mugo N, Nair G, Kiarie J, Philip NM, Pleaner M, Reddy K, Selepe P, Steyn PS, Scoville CW, Smit J, Thomas KK, Donnell D, Baeten JM; ECHO Trial Consortium. High HIV incidence among young women in South Africa: Data from a large prospective study. PLoS One. 2022 Jun 3;17(6):e0269317. doi: 10.1371/journal.pone.0269317. eCollection 2022.
Tanko RF, Bunjun R, Dabee S, Jaumdally SZ, Onono M, Nair G, Palanee-Phillips T, Harryparsad R, Happel AU, Gamieldien H, Qumbelo Y, Sinkala M, Scoville CW, Heller K, Baeten JM, Bosinger SE, Burgener A, Heffron R, Jaspan HB, Passmore JAS. The Effect of Contraception on Genital Cytokines in Women Randomized to Copper Intrauterine Device, Depot Medroxyprogesterone Acetate, or Levonorgestrel Implant. J Infect Dis. 2022 Sep 13;226(5):907-919. doi: 10.1093/infdis/jiac084.
Mugo NR, Stalter RM, Heffron R, Rees H, Scoville CW, Morrison C, Kourtis AP, Bukusi E, Beksinka M, Philip NM, Beesham I, Deese J, Edward V, Donnell D, Baeten JM; Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial Consortium. Incidence of Herpes Simplex Virus Type 2 Infection Among African Women Using Depot Medroxyprogesterone Acetate, a Copper Intrauterine Device, or a Levonorgestrel Implant for Contraception: A Nested Randomized Trial. Clin Infect Dis. 2022 Sep 10;75(4):586-595. doi: 10.1093/cid/ciab1027.
Donnell D, Beesham I, Welch JD, Heffron R, Pleaner M, Kidoguchi L, Palanee-Phillips T, Ahmed K, Baron D, Bukusi EA, Louw C, Mastro TD, Smit J, Batting JR, Malahleha M, Bailey VC, Beksinska M, Rees H, Baeten JM; ECHO Trial Consortium. Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study. Lancet HIV. 2021 Aug;8(8):e495-e501. doi: 10.1016/S2352-3018(21)00048-5. Epub 2021 Jun 11.
Beksinska M, Issema R, Beesham I, Lalbahadur T, Thomas K, Morrison C, Hofmeyr GJ, Steyn PS, Mugo N, Palanee-Phillips T, Ahmed K, Nair G, Baeten JM, Smit J. Weight change among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Findings from a randomised, multicentre, open-label trial. EClinicalMedicine. 2021 Apr 6;34:100800. doi: 10.1016/j.eclinm.2021.100800. eCollection 2021 Apr.
Beesham I, Welch JD, Heffron R, Pleaner M, Kidoguchi L, Palanee-Phillips T, Ahmed K, Baron D, Bukusi EA, Louw C, Mastro TD, Smit J, Batting JR, Malahleha M, Bailey VC, Beksinska M, Donnell D, Baeten JM; ECHO Trial Consortium. Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial. J Int AIDS Soc. 2020 May;23(5):e25491. doi: 10.1002/jia2.25491.
Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial Consortium. HIV incidence among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: a randomised, multicentre, open-label trial. Lancet. 2019 Jul 27;394(10195):303-313. doi: 10.1016/S0140-6736(19)31288-7. Epub 2019 Jun 13.
Other Identifiers
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523201
Identifier Type: -
Identifier Source: org_study_id
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