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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DE031249 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers.
The study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV text messages (TM HIV) | Experimental | Eligible participants randomized into this arm will receive text messages to reduce the risk for HIV and promote HIV testing. |
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| TM HL | Active Comparator | Eligible participants randomized into this arm will receive text messages to promote healthy living, but not specific to HIV risk or testing.. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TM HIV | Behavioral | Participants will receive 5 intervention text messages (TM) about HIV risk and testing per week for the first 3 months and 3 messages per week for the last 3 months of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that obtain HIV testing | The total number of participants that obtain HIV testing will be assessed from answers to a question in a study questionnaire. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to pre-exposure prophylaxis (PrEP) | Participants will be asked to complete a study questionnaire where they will be asked if they adhered to PrEP. | baseline, 3 months, 6 months, 12 months |
| PrEp Uptake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Henshaw, DDS, MPH | Contact | :617-358-6111 | mhenshaw@bu.edu | |
| Gabriel Federo Hungria, MD, MSCR | Contact | 617-358-6490 | gfedero@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Henshaw, DDS, MPH | Boston University Goldman School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South End Community Health Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2024 | Aug 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2023 | Aug 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| TM HL | Behavioral | Participants will receive 5 intervention text messages (TM) about promoting healthy living (HL) per week for the first 3 months and 3 messages per week for the last 3 months of the intervention. |
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Percentage of participants who started PrEP since the last assessment
| 3 months, 6 months, 12 months |
| Condom use | Percentage of participants who used condoms consistently within the last month or at their last sexual encounter since the start of the intervention. | 3 months, 6 months, 12 months |
| Intravenous Drug Use (IDU) | Among participants reporting IDU, percentage of participants who report using clean needles since the start of the intervention | 3 months, 6 months, 12 months |
| Self-efficacy score | This outcome will be assessed using a one-item measure with a 5-point Likert scale where: 1 = "Not at all", 2 = "Somewhat", 3 = "Undecided", 4 = "Not really", and 5 = "Very much". HIgher scores are more favorable. | 6 months, 12 months |
| Motivation to perform behaviours that reduce HIV risk | This outcome will be assessed using a one-item measure with a 5-point Likert scale where: 1 = "Not at all", 2 = "Somewhat", 3 = "Undecided", 4 = "Not really", and 5 = "Very much". HIgher scores are more favorable. | 3 months, 6 months, 12 months |
| Outcome expectations regarding behaviors to reduce HIV risk. | This outcome will be assessed using a one-item measure with a 5-point Likert scale where: 1 = "Not at all", 2 = "Somewhat", 3 = "Undecided", 4 = "Not really", and 5 = "Very much". HIgher scores are more favorable. | 3 months, 6 months, 12 months |
| East Boston Neighborhood Health Center | Recruiting | Boston | Massachusetts | 02128 | United States |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |