Acceptability of Different Contraceptive Injection Types Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 356 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Uganda | Rakai Health Sciences Program | Kalisizo |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins Bloomberg School of Public Health | Bill and Melinda Gates Foundation, Rakai Health Sciences Program, Society of Family Planning |
Uganda,
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® Press versus intramuscular Depo-Provera among HIV-positive women in Rakai, Uganda: a randomized c — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Preferred injection method | Preference for subcutaneous injection, intramuscular injection, or no preference between the two | 6 months | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Side effects | Including pain/injection/soreness at injection site and other reported side effects | Baseline, 3 months, 6 months | No |
| Secondary | Continuation of use of injectables | Proportion of enrolled women who continue using injectable contraception at follow up visits | 3 months, 6 months | No |
| Secondary | Future use intentions | Whether plans to use injectable contraception again in three months | Baseline, 3 months, 6 months | No |
| Secondary | 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 | No |
| Secondary | Level of satisfaction with method | Level of satisfaction with method of contraception injection received | Baseline, 3 months, 6 months | No |