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

Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acceptability of Different Contraceptive Injection Types

Intervention: DepoSubQ Provera 104 in Uniject (Drug); Intramuscular DMPA (Drug)

Phase: N/A

Status: Completed

Sponsored by: Johns Hopkins Bloomberg School of Public Health

Official(s) and/or principal investigator(s):
Ron H Gray, MD, MSC, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Preferred injection method

Secondary outcome:

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

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

Pregnancy incidence

Side effects

Continuation of use of injectables

Future use intentions

Likelihood of recommending method to a friend

Level of satisfaction with method

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Rakai Health Sciences Program, Kalisizo, Uganda
Additional Information

abstract

Starting date: April 2012
Last updated: September 16, 2014

Page last updated: August 23, 2015

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