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| ID | Type | Description | Link |
|---|---|---|---|
| DP12-001 | Other Grant/Funding Number | CDC |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| Grady Health System | OTHER |
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This trial will evaluate a multi-component, clinic-based intervention aimed at increasing dual protection strategy selection and adherence among young African American females at an urban family planning clinic. Dual protection is the use of contraceptive strategies to prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is an unblinded randomized controlled trial; participants will either get the interactive multimedia platform focused on DP strategies with intervention arm counseling or the standard of care arm counseling.
The study will recruit 710 African American females aged 14-19 who are attending the Grady Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health care.
The trial will recruit and enroll 710 young women presenting to the clinic for clinical care who have the following characteristics:
Those enrolled will be in the study for 12 months. Young women who are eligible and give written consent or assent for study participation will be enrolled. Half will be randomized to the control arm, half to the intervention arm.
Control arm (standard of care) includes individual clinical care and standard of care counseling consistent with protocols at the TSC, with study visits for data collection at enrollment, 6 months, and 12 months, during which any medical care or counseling that they would normally get will also be provided. Control arm participants will also get telephone calls from clinic staff to update their contact information and remind them of upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3 weeks and 5 months after the 6 month visit.
Intervention arm, consisting of the following intervention components:
Enrollment visit
Booster counseling via phone at about 3 weeks and 5 months after the enrollment visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE).
6 month visit
At the final study visit at 12 months there is no difference between the counseling provided to the two groups; participants in both arms will receive the clinic standard of care.
Participants in both arms of the study will follow the same data collection procedures throughout the study:
Throughout the study, all participants will be encouraged to come in for evaluation if they have any concerns. Any data from pregnancy or STI testing at these interim clinic visits will be later collected via chart review. If participants seek reproductive health care at other facilities during the study period, records will be requested with participant permission, and data from pregnancy or STI testing at these outside clinic visits will be collected via review of records received.
We will examine the efficacy of the intervention arm relative to control arm across the following primary behavioral and biologic outcomes over the 12 months of follow-up:
A small pilot study was be conducted prior to the initiation of enrollment in the main study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | The control arm receives the clinic standard of care counseling. This includes individual clinical care and counseling consistent with protocols at the Grady Health System Teen Services Clinic, with study visits at enrollment, 6 months, and 12 months, during which any medical care or counseling included in the clinic standard of care will be provided. All control group members will see a provider on the day of enrollment. Control arm participants will get phone calls from clinic staff to update their contact information and remind them of upcoming appointments at 3 weeks and 5 months after both the enrollment visit and the 6 month visit. Participants may visit the clinic at any time and will be encouraged to come into the clinic for any concerns. If they have an interim visit during the study period, they will receive the clinic standard of care. |
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| Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive multimedia platform | Behavioral | An interactive platform that includes video vignettes of young women who are choosing dual protection strategies (based on a synthesis of focus group data from members of the TSC patient population), as well as true/false questions to build knowledge about dual protection and dispel common myths about contraceptive strategies. There will also be reflection questions that encourage participants to consider values and priorities in their own lives that may influence their dual protection strategy selection. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant selection of an effective dual protection (DP) strategy | Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following:
| 6 months |
| Participant report of adherence to DP strategy | By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes:
| 3 months |
| Time to first biologic event (pregnancy or diagnosis with STI) in participants | Measured by date of positive lab test ("biologic event" refers to a positive pregnancy test or diagnosis with chlamydia, gonorrhea or trichomonas infection). | Within 12 month period following enrollment |
| Incidence of pregnancy and sexually transmitted infections (STIs) | Includes the proportion of participants with a lab-confirmed diagnosis of pregnancy or lab-confirmed diagnosis with infection with chlamydia, gonorrhea or trichomonas within the 12 month follow-up period (testing either performed at study site clinic and documented at study visits and via chart review, or diagnosed by outside labs with documentation obtained via release of information procedures) | Within 12 month period following enrollment |
| Participant selection of an effective dual protection (DP) strategy | Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following:
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| Measure | Description | Time Frame |
|---|---|---|
| Participant level of reproductive health knowledge (percentage correct of knowledge questions) | Knowledge about contraceptives and STIs, as measured by correct answers to knowledge questions on ACASI questionnaires. | 6 months |
| Participant intention to use DP strategy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Kottke, MD MPH MBA | Emory University; Grady Health System | Principal Investigator |
| Jessica Sales, PhD | Emory University | Principal Investigator |
| Athena Kourtis, MD PhD MPH | Centers for Disease Control and Prevention | Principal Investigator |
| Peggy Goedken, MPH | Emory University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System Teen Services Clinic | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36413049 | Derived | Kottke MJ, Sales JM, Goedken P, Brown JL, Hatfield-Timajchy K, Koumans EH, Hardin JW, Kraft JM, Kourtis AP. 2gether: A Clinic-Based Intervention to Increase Dual Protection from Sexually Transmitted Infections and Pregnancy in Young African American Females. J Womens Health (Larchmt). 2023 Jan;32(1):29-38. doi: 10.1089/jwh.2022.0209. Epub 2022 Nov 22. | |
| 32667837 |
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| Intervention arm counseling | Behavioral | Counseling for the intervention group will follow carefully developed guides and incorporate the participants' answers to the reflection questions in the interactive multi-media component. This counseling has a set structure (set forth in separate counseling guides for health care providers and nurse educators), incorporates motivational interviewing techniques, includes multiple opportunities for role play, and is designed to be patient-centered. |
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| Standard of care counseling | Behavioral | Standard of care counseling is provided by health care providers and health educators at TSC. It incorporates extensive counseling on methods to prevent both unintended pregnancy and sexually transmitted infections, however the structure of the counseling and techniques used are dependent on the standard practice of each provider or educator. This counseling does not incorporate answers to reflection questions from the multi-media platform because control arm participants will not view this content. |
|
| 12 months |
| Participant report of adherence to DP strategy | By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes:
| 6 months |
| Participant report of adherence to DP strategy | By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes:
| 9 months |
| Participant report of adherence to DP strategy | By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes:
| 12 months |
| Participant selection of an effective dual protection (DP) strategy | Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following:
| At enrollment visit |
Whether or not participant self-reports intention to use an effective DP strategy in the future, as measured by responses on ACASI questionnaires. |
| 6 months |
| Participant reproductive health self-efficacy | Whether or not participant reported high self-efficacy for condom use, contraceptive use, and communication with partner on reproductive health topics, as measured by responses on ACASI questionnaires. | 6 months |
| Participant report of STI testing | Frequency of self-reported STI testing by participant and partner(s) and result-sharing with partner(s), as measured by responses to ACASI questionnaires. | 6 months |
| Participant report of partner communication | Self-reported frequency of communication with partner on reproductive health topics, as measured by responses on ACASI questionnaires. | 6 months |
| Participant level of reproductive health knowledge (percentage correct of knowledge questions) | Knowledge about contraceptives and STIs, as measured by correct answers to knowledge questions on ACASI questionnaires. | 12 months |
| Participant intention to use DP strategy | Whether or not participant self-reports intention to use an effective DP strategy in the future, as measured by responses on ACASI questionnaires. | 12 months |
| Participant report of STI testing | Frequency of self-reported STI testing by participant and partner(s) and result-sharing with partner(s), as measured by responses to ACASI questionnaires. | 12 months |
| Participant reproductive health self-efficacy | Whether or not participant reported high self-efficacy for condom use, contraceptive use, and communication with partner on reproductive health topics, as measured by responses on ACASI questionnaires. | 12 months |
| Participant report of partner communication | Self-reported frequency of communication with partner on reproductive health topics, as measured by responses on ACASI questionnaires. | 12 months |
| Kraft JM, Snead MC, Brown JL, Sales JM, Kottke MJ, Hatfield-Timajchy K, Goedken P. Reproductive Coercion Among African American Female Adolescents: Associations with Contraception and Sexually Transmitted Diseases. J Womens Health (Larchmt). 2021 Mar;30(3):429-437. doi: 10.1089/jwh.2019.8236. Epub 2020 Jul 13. |
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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