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

Study Overview
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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.

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

Conditions
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Acceptability of Different Contraceptive Injection Types

Intervention / Treatment
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* Drug: DepoSubQ Provera 104 in Uniject
* Drug: Intramuscular DMPA


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Depo-SubQ Provera 104 in Uniject<br> | Drug: DepoSubQ Provera 104 in Uniject<br>* DepoSubQ Provera 104 in Uniject<br>|
| Other: Intramuscular DMPA<br> | Drug: Intramuscular DMPA<br>* Intramuscular DMPA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preferred injection method | 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 | 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 | 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 | 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 | Including pain/injection/soreness at injection site and other reported side effects | Baseline, 3 months, 6 months | 
| Continuation of use of injectables | Proportion of enrolled women who continue using injectable contraception at follow up visits | 3 months, 6 months | 
| Future use intentions | Whether plans to use injectable contraception again in three months | Baseline, 3 months, 6 months | 
| Likelihood of recommending method to a friend | How likely participant would be to recommend this contraceptive method to a friend | Baseline, 3 months, 6 months | 
| Level of satisfaction with method | Level of satisfaction with method of contraception injection received | Baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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injectable contraception, acceptability, intramuscular, subcutaneous