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Couple User Preferences in Dual Purpose Prevention Products (CUPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04023799
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : February 17, 2020
Sponsor:
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)
Information provided by (Responsible Party):
Microbicide Trials Network

Brief 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. Post-survey explanatory in-depth interviews (IDIs) will be conducted with a subset of participants to explore DPP product-related decisions..

Condition or disease
HIV Prevention Contraception Behavior

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Dual Purpose Prevention (DPP) Product Preferences Among Couples
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Attributes of a DPP product that influence preferences among heterosexual couples [ Time Frame: 12-15 months during Q2 2019/Q4 2020 ]
    Survey questionnaires

  2. 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)


Secondary Outcome Measures :
  1. Salient relationship-based and decision-making factors that influence DPP product interest and preferences [ Time Frame: 12-15 months during Q2 2019/Q4 2020 ]
    Survey questionnaires

  2. 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 ]
    Survey questionnaires


Other Outcome Measures:
  1. Salient relationship characteristics, norms and communication factors that influenced participants' decision-making process [ Time Frame: 12-15 months during Q2 2019/Q4 2020 ]
    Survey questionnaires

  2. Differences in product preferences, when comparing individual to couples' choices, that characterize the male partner's role in females' preferences [ Time Frame: 12-15 months during Q2 2019/Q4 2020 ]
    Discrete-Choice Experiments (DCE)

  3. Likelihood of using each DPP product, overall and by subgroup, as estimated through analysis of DCE data [ Time Frame: 12-15 months during Q2 2019/Q4 2020 ]
    Discrete-Choice Experiments (DCE)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

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:

  1. Able and willing to provide written informed consent in one of the study languages.
  2. Able and willing to complete the required study procedures.
  3. Currently in a heterosexual relationship (living together or not) for at least 3 months (by self-report) with the other member of the couple.
  4. At time of Enrollment, expressed interest in contraception and/or HIV prevention (by self-report).

    For female partner:

  5. Between the ages of 18 to 40 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs).
  6. HIV negative (by self-report).

    For male partner:

  7. Aged 18 years or older at Enrollment, verified per site SOPs.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023799


Contacts
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Contact: MTN Regulatory 412-641-8999 mtnregulatory@mtnstopshiv.org

Locations
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Uganda
Makerere University - Johns Hopkins University (MU-JHU) Research Recruiting
Kampala, Uganda
Contact: Juliane Etima, MA Psy       jetima@mujhu.org   
Zimbabwe
Zengeza Clinical Research Site Recruiting
Harare, Zimbabwe
Contact: Petina Musara, BSW       pmusara@uzchs-ctrc.org   
Sponsors and Collaborators
Microbicide Trials Network
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)
Investigators
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Study Chair: Alexandra Minnis, PhD Research Triangle Institute (RTI) International

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Responsible Party: Microbicide Trials Network
ClinicalTrials.gov Identifier: NCT04023799    
Other Study ID Numbers: MTN-045
UM1AI068633 ( U.S. NIH Grant/Contract )
UM1AI068615 ( U.S. NIH Grant/Contract )
UM1AI106707 ( U.S. NIH Grant/Contract )
38598 ( Other Identifier: DAIDS )
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No