Couple User Preferences in Dual Purpose Prevention Products

NCT04023799 | Completed

• 5 other identifiers: MTN-045UM1AI068633UM1AI068615UM1AI10670738598
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

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..

Conditions

HIV Prevention; Contraception Behavior

Outcome Measures

Primary Outcomes (2)

• Attributes of a DPP product that influence preferences among heterosexual couples

  Survey questionnaires

  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)

  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

  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

  12-15 months during Q2 2019/Q4 2020

Other Outcomes (3)

• Salient relationship characteristics, norms and communication factors that influenced participants' decision-making process

  12-15 months during Q2 2019/Q4 2020

• Differences in product preferences, when comparing individual to couples' choices, that characterize the male partner's role in females' preferences

  12-15 months during Q2 2019/Q4 2020

• Likelihood of using each DPP product, overall and by subgroup, as estimated through analysis of DCE data

  12-15 months during Q2 2019/Q4 2020

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• Potential participants who meet the following criteria will be excluded from the study along with their partner:
• \. 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.

Sponsors & Collaborators

• Microbicide Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Makerere University - Johns Hopkins University (MU-JHU) Research

Kampala, Uganda

Location

Zengeza Clinical Research Site

Harare, Zimbabwe

Location

Related Publications (1)

• 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.

  PMID: 35674885 RESULT

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Alexandra Minnis, PhD

  Research Triangle Institute (RTI) International

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: July 18, 2019
• Study Start: January 21, 2020
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

ZI (1); UG (1)