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Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda

This study has been completed.
Sponsor:
Collaborators:
Society of Family Planning
Bill and Melinda Gates Foundation
Rakai Health Sciences Program
Information provided by (Responsible Party):
Ronald Gray, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01578447
First received: April 4, 2012
Last updated: September 16, 2014
Last verified: September 2014

April 4, 2012
September 16, 2014
April 2012
March 2013   (final data collection date for primary outcome measure)
Preferred injection method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Preference for subcutaneous injection, intramuscular injection, or no preference between the two
Preferred injection method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Preference for subcutaneous injection, intramuscular injection, or no preference bewteen the two
Complete list of historical versions of study NCT01578447 on ClinicalTrials.gov Archive Site
  • Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providers [ Time Frame: Baseline, 10 months ] [ Designated as safety issue: No ]
    E.g., problems encountered, preference to give more, same amount, or fewer of each kind of injection, advantages and disadvantages of each kind of injection, difficulty of administration, perception of client experience, which type of injectable prefers to administer, whether preferences are impacted by HIV status of client
  • Hypothetical acceptability of contraceptive injections provided by community health care worker, trained and trusted friend or family member, or self-administration [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    In this study, all injections will be provided by a trained medical professional, but we will ask women if they would hypothetically find provision by community health workers, a trained trusted friend or family member, or self-administration acceptable
  • Pregnancy incidence [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Will not be compared according to study product, since all participants will utilize both products in this crossover trial.
  • Side effects [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Including pain/injection/soreness at injection site and other reported side effects
  • Continuation of use of injectables [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Proportion of enrolled women who continue using injectable contraception at follow up visits
  • Future use intentions [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Whether plans to use injectable contraception again in three months
  • Likelihood of recommending method to a friend [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    How likely participant would be to recommend this contraceptive method to a friend
  • Level of satisfaction with method [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Level of satisfaction with method of contraception injection received
Same as current
Not Provided
Not Provided
 
Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda
Acceptability of Depo-subQ Provera 104 in Uniject Versus Intramuscular Depo-Provera Among HIV-positive Women and Family Planning Providers in Rakai, Uganda

The purpose of this study is to assess acceptability and side effects of a low-dose injectable contraceptive formulation which is delivered under the skin (subcutaneously), as compared with injectable contraception delivered into the muscle (intramuscularly) among adult HIV-positive women who attend mobile clinics for HIV care and wish to use injectable contraception. The investigators will also assess experiences experiences delivering these two types of injections among health care providers working within the HIV care clinics.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Acceptability of Different Contraceptive Injection Types
  • Drug: DepoSubQ Provera 104 in Uniject
    DepoSubQ Provera 104 in Uniject
  • Drug: Intramuscular DMPA
    Intramuscular DMPA
  • Depo-SubQ Provera 104 in Uniject
    Intervention: Drug: DepoSubQ Provera 104 in Uniject
  • Intramuscular DMPA
    Intervention: Drug: Intramuscular DMPA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
356
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV+
  • Woman aged 18-45
  • Wishes to prevent pregnancy by use of injectable contraception and intends to continue using injectable contraception for next nine months
  • Medically eligible for injectable contraception
  • Capable of providing informed consent
  • Willing to provide contact information
  • Agrees to trial participation
  • Intends to live in the area for the next nine months
  • May or may not be currently using a first-line antiretroviral therapy regimen (includes: AZT/3TC/EFV; AZT/3TC/NVP; CBV/EFV; D4T/3TC/EFV; D4T/3TC/NVP; TDF/3TC/EFV; TDF/3TC/NVP)

Exclusion Criteria:

  • Currently pregnant
  • Desires pregnancy within next nine months
  • Contraindications to using injectable contraception
  • On second-line antiretroviral therapy regimen
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01578447
00003213
Yes
Ronald Gray, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • Society of Family Planning
  • Bill and Melinda Gates Foundation
  • Rakai Health Sciences Program
Principal Investigator: Ron H Gray, MD, MSC Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP