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

NCT ID: NCT01578447

Last Updated: 2014-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acceptability of Different Contraceptive Injection Types

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Depo-SubQ Provera 104 in Uniject

Group Type OTHER

DepoSubQ Provera 104 in Uniject

Intervention Type DRUG

DepoSubQ Provera 104 in Uniject

Intramuscular DMPA

Group Type OTHER

Intramuscular DMPA

Intervention Type DRUG

Intramuscular DMPA

Interventions

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DepoSubQ Provera 104 in Uniject

DepoSubQ Provera 104 in Uniject

Intervention Type DRUG

Intramuscular DMPA

Intramuscular DMPA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Rakai Health Sciences Program

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Ronald Gray

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ron H Gray, MD, MSC

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Rakai Health Sciences Program

Kalisizo, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type RESULT
PMID: 24332432 (View on PubMed)

Other Identifiers

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00003213

Identifier Type: -

Identifier Source: org_study_id

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