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 Institute for Population and Reproductive Health
Rakai Health Sciences Program, Rakai, Uganda
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: March 15, 2013
Last verified: March 2013
  Purpose

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 Intervention
Acceptability of Different Contraceptive Injection Types
Drug: DepoSubQ Provera 104 in Uniject
Drug: Intramuscular DMPA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Preferred injection method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Preference for subcutaneous injection, intramuscular injection, or no preference between the two


Secondary Outcome Measures:
  • 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


Enrollment: 356
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Depo-SubQ Provera 104 in Uniject Drug: DepoSubQ Provera 104 in Uniject
DepoSubQ Provera 104 in Uniject
Intramuscular DMPA Drug: Intramuscular DMPA
Intramuscular DMPA

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578447

Locations
Uganda
Rakai Health Sciences Program
Kalisizo, Uganda
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Society of Family Planning
Bill and Melinda Gates Institute for Population and Reproductive Health
Rakai Health Sciences Program, Rakai, Uganda
Investigators
Principal Investigator: Ron H Gray, MD, MSC Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Ronald Gray, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01578447     History of Changes
Other Study ID Numbers: 00003213
Study First Received: April 4, 2012
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board
Uganda: Research Ethics Committee
Uganda: National Council for Science and Technology

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
injectable contraception
acceptability
intramuscular
subcutaneous

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

ClinicalTrials.gov processed this record on August 26, 2014