Clinical trial NCT04023799: Couple User Preferences in Dual Purpose Prevention Products
Official title: Dual Purpose Prevention (DPP) Product Preferences Among Couples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Prevention
Contraception Behavior
Lead sponsor: Microbicide Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2019-07-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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..

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.

Eligibility 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.

Primary outcomes:
measure: Attributes of a DPP product that influence preferences among heterosexual couples
timeFrame: 12-15 months during Q2 2019/Q4 2020
measure: 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)
timeFrame: 12-15 months during Q2 2019/Q4 2020
Secondary outcomes:
measure: Salient relationship-based and decision-making factors that influence DPP product interest and preferences
timeFrame: 12-15 months during Q2 2019/Q4 2020
measure: Differences in attributes salient to preferences by sociodemographic factors such as age and parity that may reflect lifecourse stage
timeFrame: 12-15 months during Q2 2019/Q4 2020
Other outcomes:
measure: Salient relationship characteristics, norms and communication factors that influenced participants' decision-making process
timeFrame: 12-15 months during Q2 2019/Q4 2020
measure: Differences in product preferences, when comparing individual to couples' choices, that characterize the male partner's role in females' preferences
timeFrame: 12-15 months during Q2 2019/Q4 2020
measure: Likelihood of using each DPP product, overall and by subgroup, as estimated through analysis of DCE data
timeFrame: 12-15 months during Q2 2019/Q4 2020
Locations:
city: Kampala
country: Uganda
facility: Makerere University - Johns Hopkins University (MU-JHU) Research
city: Harare
country: Zimbabwe
facility: Zengeza Clinical Research Site
Study officials:
affiliation: Research Triangle Institute (RTI) International
name: Alexandra Minnis, PhD
role: STUDY_CHAIR
References:
citation: 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.