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OpenTrials
Completed

NCT Number: NCT01578447

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

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Key information

Conditions

Acceptability of Different Contraceptive Injection Types

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rakai Health Sciences Program

Kalisizo, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DepoSubQ Provera 104 in Uniject

Drug

DepoSubQ Provera 104 in Uniject

Intramuscular DMPA

Drug

Intramuscular DMPA

Primary outcomes

  1. Preferred injection method

    Time frame: 6 months

    Preference for subcutaneous injection, intramuscular injection, or no preference between the two

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Rakai Health Sciences Program
  • Society of Family Planning

Registry information

Official study title

Acceptability of Depo-subQ Provera 104 in Uniject Versus Intramuscular Depo-Provera Among HIV-positive Women and Family Planning Providers in Rakai, Uganda

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2012
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.