Acceptability of Different Contraceptive Injection TypesNCT01578447
Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda
A study testing DepoSubQ Provera 104 in Uniject and Intramuscular DMPA in people with Acceptability of Different Contraceptive Injection Types, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Acceptability of Different Contraceptive Injection Types
- What is being tested?
- DepoSubQ Provera 104 in Uniject and Intramuscular DMPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- Currently pregnant
- Desires pregnancy within next nine months
- Contraindications to using injectable contraception
- On second-line antiretroviral therapy regimen
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- DepoSubQ Provera 104 in Uniject, Intramuscular DMPA
- Keywords
- injectable contraception, acceptability, intramuscular, subcutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepoSubQ Provera 104 in UnijectDrug
DepoSubQ Provera 104 in Uniject
Intramuscular DMPADrug
Intramuscular DMPA
| Study group | Role | What they receive |
|---|---|---|
| Depo-SubQ Provera 104 in Uniject | Other | Not described Receives: Drug: DepoSubQ Provera 104 in Uniject |
| Intramuscular DMPA | Other | Not described Receives: Drug: Intramuscular DMPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred injection method
Preference for subcutaneous injection, intramuscular injection, or no preference between the two
Measured: 6 months
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: 3 months, 6 months
Side effects
Including pain/injection/soreness at injection site and other reported side effects
Measured: Baseline, 3 months, 6 months
Continuation of use of injectables
Proportion of enrolled women who continue using injectable contraception at follow up visits
Measured: 3 months, 6 months
Future use intentions
Whether plans to use injectable contraception again in three months
Measured: 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
Measured: Baseline, 3 months, 6 months
Level of satisfaction with method
Level of satisfaction with method of contraception injection received
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acceptability of Different Contraceptive Injection TypesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning, Bill and Melinda Gates Foundation, Rakai Health Sciences Program
- Responsible party
- Principal investigator, Ronald Gray, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Ron H Gray, MD, MSC, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578447
- Sponsor's protocol ID
- 00003213
- Status last verified
- Sep 2014
- First submitted
- 4 Apr 2012
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24332432
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01578447
- Acronym / sponsor ID
- 00003213
- Keywords
- injectable contraception, acceptability, intramuscular, subcutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Society of Family Planning, Bill and Melinda Gates Foundation, Rakai Health Sciences Program
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depo-SubQ Provera 104 in Uniject | Other | Drug: DepoSubQ Provera 104 in Uniject |
| Intramuscular DMPA | Other | Drug: Intramuscular DMPA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Currently pregnant
- Desires pregnancy within next nine months
- Contraindications to using injectable contraception
- On second-line antiretroviral therapy regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DepoSubQ Provera 104 in UnijectDepoSubQ Provera 104 in Uniject | Drug | Depo-SubQ Provera 104 in Uniject |
| Intramuscular DMPAIntramuscular DMPA | Drug | Intramuscular DMPA |
Primary outcome
Preferred injection method
Time frame: 6 months
Preference for subcutaneous injection, intramuscular injection, or no preference between the two
8 secondary outcomes
Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providers
Time frame: Baseline, 10 months
Hypothetical acceptability of contraceptive injections provided by community health care worker, trained and trusted friend or family member, or self-administration
Time frame: Baseline, 3 months, 6 months
Pregnancy incidence
Time frame: 3 months, 6 months
Side effects
Time frame: Baseline, 3 months, 6 months
Continuation of use of injectables
Time frame: 3 months, 6 months
Future use intentions
Time frame: Baseline, 3 months, 6 months
Likelihood of recommending method to a friend
Time frame: Baseline, 3 months, 6 months
Level of satisfaction with method
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Results publication: PubMed 24332432Polis 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron H Gray, MD, MSC principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DepoSubQ Provera 104 in Uniject and Intramuscular DMPA in people with Acceptability of Different Contraceptive Injection Types, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferred injection method (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01578447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.