Sexual and Reproductive Health Clinical Trial
Official title:
K24: Advancing Reproductive Health: Women's Input on Sexual Health (Project WISH)
The purpose of this study is to answer the following questions: (a) how do sexual and reproductive health (SRH) delivery method characteristics play a role in user preference for specific SRH methods; (b) can we understand the interplay between salient SRH product characteristics and effective use; (c) does effective use differ by indication (e.g., whether the product is for contraception or lubrication); and (d) can this knowledge help product developers better understand how to design new SRH products and develop behavioral (or point-of-care) interventions to optimize use?
Background: Sexual and reproductive health (SRH) is a global public health priority.
Providing efficacious SRH technologies that have the greatest likelihood of use will have the
greatest impact on women's health. Critical to use is "acceptability." However, current
conceptualizations of adherence and acceptability fail to fully articulate and account for
patterns of use and non-use. This research hypothesizes that a new model of use, Effective
Use, is required. If correct, and if developers utilize an Effective Use model, a shift from
the current "acceptability = adherence" paradigm would offer new insights in the development
of SRH technologies that will result in increased use and improved SRH outcomes. If the model
can be fully realized, women will have the best reproductive health technologies science can
provide. The impact on global public health would be far-reaching, affecting reproductive
health in women and men: decreasing STI incidence, minimizing unplanned pregnancies, and
decreasing morbidity and mortality due to a range of other reproductive health conditions.
Conditions: There will be 2 experimental conditions: sexual lubricant use and contraceptive
use. [NOTE: The protocol has been revised. Protocol 1 is no longer recruiting - Protocol 1:
Each participant will use 3 different SRH products for 3 months each. Recruitment for
Protocol 2 is ongoing for the contraceptive use condition only. - Protocol 2: Each
participant will use 1 product for 6 months, or 2 products, each for 3 months. This will be
dependent on the user's choice.] The sexual lubricant use condition will include gel, film,
and capsule. The contraceptive use condition will include gel, intravaginal ring, and oral
contraceptive pill. The order in which participants experience each delivery method will be
randomized.
Methodology and Data Collection: Volunteers (N~20-30) will first be screened for the study
using a brief questionnaire. Those who are interested in contraception and are eligible based
on their responses to the prescreen will then complete a clinical screening visit
(contraceptive arm only) and pregnancy test. Those who are interested in lubricants and are
eligible based on their responses to the prescreen, and those who are eligible after clinical
screening (contraception arm), will complete a survey that asks questions about demographics
and sexual and reproductive history.
During the course of the study, participants will evaluate three study products
(contraceptives OR sexual lubricants). Each product will be used for three consecutive
months. Participants will be randomly assigned to the order in which they will try the three
products. They will be given (lubricants), or prescribed (contraceptives) a three month
supply of the product at the beginning of each use period. Participants will be required to
complete a brief phone survey (<5 minutes) every day, beginning the day after they start
their first product evaluation period and continuing until they complete their final study
visit (approximately 9 months). The phone survey includes a short set of questions about
sexual behavior and product use during the time since the last phone survey (about 24 hours).
About once a month, each participant will be required to complete a web survey about their
experience with the study product.
Every three months, participants will meet with research staff and, if necessary, the study
clinician. All participants will be tested for pregnancy, and will be given, or prescribed,
the next study product. Participants will also complete an individual in-depth interview with
study staff about their experiences in the study. Participants will repeat these steps for
the final (third) study product. After a participant has tried all three products, she will
meet with a clinician (contraceptive arm only) to follow up clinically about her
contraception options post-study participation. All participants complete a final survey that
will ask about their experiences with all three study products, and about what kinds of
products, if any, they might be interested in using in the future. Participants will also
complete a final in-depth interview.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04974086 -
Electronic Sexual Reproductive Health CDS Tool at the Children's Hospital of Philadelphia
|
N/A | |
| Not yet recruiting |
NCT05817981 -
The Investigation of Knowledge and Educational Demand of Sexual and Reproductive Health Among Cancer Survivors
|
||
| Recruiting |
NCT05951673 -
Adolescent Girls Initiative for Learning and Empowerment: Impact Evaluation of a Safe Space-Based Life Skills Training and Digital Literacy Training in Nigeria Space-Based Life Skills Training and Digital Literacy Training in Nigeria
|
N/A |