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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01578447
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Acceptability of Different Contraceptive Injection Types Drug: DepoSubQ Provera 104 in Uniject Drug: Intramuscular DMPA

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Acceptability of Depo-subQ Provera 104 in Uniject Versus Intramuscular Depo-Provera Among HIV-positive Women and Family Planning Providers in Rakai, Uganda
Study Start Date : April 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Depo-SubQ Provera 104 in Uniject Drug: DepoSubQ Provera 104 in Uniject
DepoSubQ Provera 104 in Uniject
Intramuscular DMPA Drug: Intramuscular DMPA
Intramuscular DMPA

Outcome Measures

Primary Outcome Measures :
  1. Preferred injection method [ Time Frame: 6 months ]
    Preference for subcutaneous injection, intramuscular injection, or no preference between the two

Secondary Outcome Measures :
  1. Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providers [ Time Frame: Baseline, 10 months ]
    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

  2. 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 ]
    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

  3. Pregnancy incidence [ Time Frame: 3 months, 6 months ]
    Will not be compared according to study product, since all participants will utilize both products in this crossover trial.

  4. Side effects [ Time Frame: Baseline, 3 months, 6 months ]
    Including pain/injection/soreness at injection site and other reported side effects

  5. Continuation of use of injectables [ Time Frame: 3 months, 6 months ]
    Proportion of enrolled women who continue using injectable contraception at follow up visits

  6. Future use intentions [ Time Frame: Baseline, 3 months, 6 months ]
    Whether plans to use injectable contraception again in three months

  7. Likelihood of recommending method to a friend [ Time Frame: Baseline, 3 months, 6 months ]
    How likely participant would be to recommend this contraceptive method to a friend

  8. Level of satisfaction with method [ Time Frame: Baseline, 3 months, 6 months ]
    Level of satisfaction with method of contraception injection received

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578447

Rakai Health Sciences Program
Kalisizo, Uganda
Sponsors and Collaborators
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
More Information

Additional Information:
Responsible Party: Ronald Gray, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01578447     History of Changes
Other Study ID Numbers: 00003213
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Ronald Gray, Johns Hopkins Bloomberg School of Public Health:
injectable contraception

Additional relevant MeSH terms:
Medroxyprogesterone Acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral