NCT01578447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

April 4, 2012

Last Update Submit

September 16, 2014

Conditions

Acceptability of Different Contraceptive Injection Types

Keywords

injectable contraceptionacceptabilityintramuscularsubcutaneous

Outcome Measures

Primary Outcomes (1)

  • Preferred injection method

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

    6 months

Secondary Outcomes (8)

  • Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providers

    Baseline, 10 months

  • Hypothetical acceptability of contraceptive injections provided by community health care worker, trained and trusted friend or family member, or self-administration

    Baseline, 3 months, 6 months

  • Pregnancy incidence

    3 months, 6 months

  • Side effects

    Baseline, 3 months, 6 months

  • Continuation of use of injectables

    3 months, 6 months

  • +3 more secondary outcomes

Study Arms (2)

Depo-SubQ Provera 104 in Uniject

OTHER
Drug: DepoSubQ Provera 104 in Uniject

Intramuscular DMPA

OTHER
Drug: Intramuscular DMPA

Interventions

DepoSubQ Provera 104 in UnijectDRUG

DepoSubQ Provera 104 in Uniject

Depo-SubQ Provera 104 in Uniject
Intramuscular DMPADRUG

Intramuscular DMPA

Intramuscular DMPA

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Currently pregnant
  • Desires pregnancy within next nine months
  • Contraindications to using injectable contraception
  • On second-line antiretroviral therapy regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rakai Health Sciences Program

Kalisizo, Uganda

Location

Related Publications (1)

  • Polis CB, Nakigozi GF, Nakawooya H, Mondo G, Makumbi F, Gray RH; Members of the Rakai Health Sciences Program Sayana Press study team. Preference for Sayana(R) Press versus intramuscular Depo-Provera among HIV-positive women in Rakai, Uganda: a randomized crossover trial. Contraception. 2014 May;89(5):385-95. doi: 10.1016/j.contraception.2013.11.008. Epub 2013 Nov 15.

    PMID: 24332432RESULT

Study Officials

  • Ron H Gray, MD, MSC

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 17, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

UG(1)