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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
| Rakai Health Sciences Program | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depo-SubQ Provera 104 in Uniject | Other |
| |
| Intramuscular DMPA | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DepoSubQ Provera 104 in Uniject | Drug | DepoSubQ Provera 104 in Uniject |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Preferred injection method | Preference for subcutaneous injection, intramuscular injection, or no preference between the two | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron H Gray, MD, MSC | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rakai Health Sciences Program | Kalisizo | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24332432 | Result | 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. |
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| Intramuscular DMPA |
| Drug |
Intramuscular DMPA |
|
| 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 |