HIV PreventionCUPIDNCT04023799
Couple User Preferences in Dual Purpose Prevention Products
An observational study of HIV Prevention and Contraception Behavior, run by Microbicide Trials Network at 2 sites in 2 countries.
Trial summary
MTN-045 is a cross-sectional study that will utilize questionnaires, including Discrete-Choice Experiments (DCE) and joint decision tasks, to assess couples' preferences related to dual purpose prevention (DPP) products that could be used to prevent unintended pregnancies and HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Contraception Behavior
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jan 2020to 5 Nov 2020
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The MTN-045 study population will consist of approximately 400 heterosexual sub-Saharan African couples of reproductive age who have been in a relationship for ≥ 3 months and are interested in contraception and/or HIV prevention. Women who are currently using contraceptives as well as those not using contraceptives will be eligible. Couples who are living together as well as those not living together will be eligible.
Who may be able to join
- Each member of the couple must meet all of the following criteria to be eligible for inclusion in the study, and both members of the couple must be willing and eligible for the couple to enroll:
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- Currently in a heterosexual relationship (living together or not) for at least 3 months (by self-report) with the other member of the couple.
- At time of Enrollment, expressed interest in contraception and/or HIV prevention (by self-report).
- For female partner:
Show all 10Show fewer
- Between the ages of 18 to 40 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs).
- HIV negative (by self-report).
- For male partner:
- Aged 18 years or older at Enrollment, verified per site SOPs.
Who cannot join
- Potential participants who meet the following criteria will be excluded from the study along with their partner:
- 1. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe (including risk for IPV as a result of study participation), complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Uganda1 site
Makerere University - Johns Hopkins University (MU-JHU) Research
Kampala
About this study
Official title: Dual Purpose Prevention (DPP) Product Preferences Among Couples
MTN-045 is a cross-sectional study that will utilize questionnaires, including Discrete-Choice Experiments (DCE) and joint decision tasks, to assess couples' preferences related to dual purpose prevention (DPP) products that could be used to prevent unintended pregnancies and HIV infection. Post-survey explanatory in-depth interviews (IDIs) will be conducted with a subset of participants to explore DPP product-related decisions..
Read the detailed description
MTN-045 is a cross-sectional study that will utilize questionnaires, including DCEs and joint decision tasks, and IDIs to assess heterosexual couples' preferences related to DPP products that could be used to prevent unintended pregnancies and HIV infection. One main goal of the study is to determine heterosexual couples' preferences for a DPP product to inform product delivery and future product design to maximize uptake and willingness to use among sub-Saharan African heterosexual couples. Another main goal of the study is to assess the level of influence of the male partner on a woman's preferences for a DPP product and on her decision-making process regarding product preferences and use.
The MTN-045 study population will consist of approximately 400 heterosexual sub-Saharan African couples of reproductive age who have been in a relationship for ≥ 3 months and are interested in contraception and/or HIV prevention. Women who are currently using contraceptives as well as those not using contraceptives will be eligible. Couples who are living together as well as those not living together will be eligible. All participants will complete survey questionnaires, first separately from their partner, then followed by a joint couples' decision task. Up to 80 participants, i.e., one or both partners from a subset of up to 40 couples, will be selected to complete an IDI.
- Conditions
- HIV Prevention, Contraception Behavior
- Medical subject headings
- Contraception Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Attributes of a DPP product that influence preferences among heterosexual couples
Survey questionnaires
Measured: 12-15 months during Q2 2019/Q4 2020
Differences in DPP product attribute preferences when comparing individual to couples' choices (e.g., woman's individual preferences vs. preferences indicated through the joint couples decision task)
Discrete-Choice Experiments (DCE)
Measured: 12-15 months during Q2 2019/Q4 2020
Secondary outcomes (2)
Salient relationship-based and decision-making factors that influence DPP product interest and preferences
Survey questionnaires
Measured: 12-15 months during Q2 2019/Q4 2020
Differences in attributes salient to preferences by sociodemographic factors such as age and parity that may reflect lifecourse stage
Survey questionnaires
Measured: 12-15 months during Q2 2019/Q4 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start21 Jan 2020
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
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 HIV PreventionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbicide Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Alexandra Minnis, PhD, Study chair, Research Triangle Institute (RTI) International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023799
- Sponsor's protocol ID
- MTN-045
- Other IDs
- UM1AI068633, UM1AI068615, UM1AI106707, 38598
- Acronym
- CUPID
- Status last verified
- Oct 2022
- First submitted
- 14 Mar 2019
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Minnis AM, Etima J, Musara P, Browne EN, Mutero P, Kemigisha D, Mgodi NM, Nakabiito C, Shapley-Quinn MK, Stoner MCD, Hartmann M, Macagna N, Piper J, van der Straten A. Couples' Preferences for "2 in 1" Multipurpose Prevention Technologies to Prevent Both HIV and Pregnancy: Results of a Discrete Choice Experiment in Uganda and Zimbabwe. AIDS Behav. 2022 Dec;26(12):3848-3861. doi: 10.1007/s10461-022-03713-6.
PubMed 35674885
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Purpose Prevention (DPP) Product Preferences Among Couples
- ClinicalTrials.gov ID
- NCT04023799
- Acronym / sponsor ID
- CUPID / MTN-045
- Conditions
- HIV Prevention, Contraception Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Microbicide Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- 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.
MTN-045 is a cross-sectional study that will utilize questionnaires, including Discrete-Choice Experiments (DCE) and joint decision tasks, to assess couples' preferences related to dual purpose prevention (DPP) products that could be used to prevent unintended pregnancies and HIV infection. Post-survey explanatory in-depth interviews (IDIs) will be conducted with a subset of participants to explore DPP product-related decisions..
Detailed description
MTN-045 is a cross-sectional study that will utilize questionnaires, including DCEs and joint decision tasks, and IDIs to assess heterosexual couples' preferences related to DPP products that could be used to prevent unintended pregnancies and HIV infection. One main goal of the study is to determine heterosexual couples' preferences for a DPP product to inform product delivery and future product design to maximize uptake and willingness to use among sub-Saharan African heterosexual couples. Another main goal of the study is to assess the level of influence of the male partner on a woman's preferences for a DPP product and on her decision-making process regarding product preferences and use.
The MTN-045 study population will consist of approximately 400 heterosexual sub-Saharan African couples of reproductive age who have been in a relationship for ≥ 3 months and are interested in contraception and/or HIV prevention. Women who are currently using contraceptives as well as those not using contraceptives will be eligible. Couples who are living together as well as those not living together will be eligible. All participants will complete survey questionnaires, first separately from their partner, then followed by a joint couples' decision task. Up to 80 participants, i.e., one or both partners from a subset of up to 40 couples, will be selected to complete an IDI.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The MTN-045 study population will consist of approximately 400 heterosexual sub-Saharan African couples of reproductive age who have been in a relationship for ≥ 3 months and are interested in contraception and/or HIV prevention. Women who are currently using contraceptives as well as those not using contraceptives will be eligible. Couples who are living together as well as those not living together will be eligible.
Key inclusion criteria (10 listed)
- Each member of the couple must meet all of the following criteria to be eligible for inclusion in the study, and both members of the couple must be willing and eligible for the couple to enroll:
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- Currently in a heterosexual relationship (living together or not) for at least 3 months (by self-report) with the other member of the couple.
- At time of Enrollment, expressed interest in contraception and/or HIV prevention (by self-report).
Key exclusion criteria (2 listed)
- Potential participants who meet the following criteria will be excluded from the study along with their partner:
- 1. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe (including risk for IPV as a result of study participation), complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attributes of a DPP product that influence preferences among heterosexual couples
Time frame: 12-15 months during Q2 2019/Q4 2020
Survey questionnaires
Differences in DPP product attribute preferences when comparing individual to couples' choices (e.g., woman's individual preferences vs. preferences indicated through the joint couples decision task)
Time frame: 12-15 months during Q2 2019/Q4 2020
Discrete-Choice Experiments (DCE)
2 secondary outcomes
Salient relationship-based and decision-making factors that influence DPP product interest and preferences
Time frame: 12-15 months during Q2 2019/Q4 2020
Differences in attributes salient to preferences by sociodemographic factors such as age and parity that may reflect lifecourse stage
Time frame: 12-15 months during Q2 2019/Q4 2020
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 13 Oct 2022.
- Results publication: PubMed 35674885Minnis AM, Etima J, Musara P, Browne EN, Mutero P, Kemigisha D, Mgodi NM, Nakabiito C, Shapley-Quinn MK, Stoner MCD, Hartmann M, Macagna N, Piper J, van der Straten A. Couples' Preferences for "2 in 1" Multipurpose Prevention Technologies to Prevent Both HIV and Pregnancy: Results of a Discrete Choice Experiment in Uganda and Zimbabwe. AIDS Behav. 2022 Dec;26(12):3848-3861. doi: 10.1007/s10461-022-03713-6.
Related trials for HIV Prevention
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
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.
Alexandra Minnis, PhD study chair
Research Triangle Institute (RTI) International
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention and Contraception Behavior, run by Microbicide Trials Network at 2 sites in 2 countries.
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 10 inclusion and 2 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 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda, Zimbabwe. 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?
Attributes of a DPP product that influence preferences among heterosexual couples (time frame: 12-15 months during Q2 2019/Q4 2020). The study lists 2 primary outcomes in all. 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 NCT04023799, 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 13 Oct 2022.