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

September 16, 2014 updated by: Ronald Gray, Johns Hopkins Bloomberg School of Public Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kalisizo, Uganda
        • Rakai Health Sciences Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Depo-SubQ Provera 104 in Uniject
Drug: DepoSubQ Provera 104 in Uniject
DepoSubQ Provera 104 in Uniject
OTHER: Intramuscular DMPA
Drug: Intramuscular DMPA
Intramuscular DMPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preferred injection method
Time Frame: 6 months
Preference for subcutaneous injection, intramuscular injection, or no preference between the two
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 10 months
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
Baseline, 3 months, 6 months
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.
3 months, 6 months
Side effects
Time Frame: Baseline, 3 months, 6 months
Including pain/injection/soreness at injection site and other reported side effects
Baseline, 3 months, 6 months
Continuation of use of injectables
Time Frame: 3 months, 6 months
Proportion of enrolled women who continue using injectable contraception at follow up visits
3 months, 6 months
Future use intentions
Time Frame: Baseline, 3 months, 6 months
Whether plans to use injectable contraception again in three months
Baseline, 3 months, 6 months
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
Baseline, 3 months, 6 months
Level of satisfaction with method
Time Frame: Baseline, 3 months, 6 months
Level of satisfaction with method of contraception injection received
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

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

Investigators

  • Principal Investigator: Ron H Gray, MD, MSC, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (ESTIMATE)

April 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00003213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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