Trial Outcomes & Findings for Technology Enhanced Community Health Nursing (TECH-N) Study (NCT NCT01640379)
NCT ID: NCT01640379
Last Updated: 2020-06-01
Results Overview
STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
286 participants
Primary outcome timeframe
90 Days
Results posted on
2020-06-01
Participant Flow
Participant milestones
| Measure |
Intervention
Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
|
Control
Participants receive enhanced standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
137
|
|
Overall Study
COMPLETED
|
135
|
125
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some baseline tests are inconclusive because the sample was not usable, so only 269 out of 286 have results.
Baseline characteristics by cohort
| Measure |
Intervention
n=149 Participants
Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
|
Control
n=137 Participants
Participants receive enhanced standard of care
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.6 years
STANDARD_DEVIATION 2.4 • n=149 Participants
|
18.8 years
STANDARD_DEVIATION 2.4 • n=137 Participants
|
18.7 years
STANDARD_DEVIATION 2.4 • n=286 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=149 Participants
|
137 Participants
n=137 Participants
|
286 Participants
n=286 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=149 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=149 Participants
|
0 Participants
n=137 Participants
|
1 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=149 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=149 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Black or African American
|
136 Participants
n=149 Participants
|
126 Participants
n=137 Participants
|
262 Participants
n=286 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=149 Participants
|
2 Participants
n=137 Participants
|
5 Participants
n=286 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=149 Participants
|
5 Participants
n=137 Participants
|
12 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=149 Participants
|
4 Participants
n=137 Participants
|
6 Participants
n=286 Participants
|
|
Region of Enrollment
United States
|
149 participants
n=149 Participants
|
137 participants
n=137 Participants
|
286 participants
n=286 Participants
|
|
Positive Sexually Transmitted Infection Test (GC or CT)
|
16 Participants
n=142 Participants • Some baseline tests are inconclusive because the sample was not usable, so only 269 out of 286 have results.
|
9 Participants
n=127 Participants • Some baseline tests are inconclusive because the sample was not usable, so only 269 out of 286 have results.
|
25 Participants
n=269 Participants • Some baseline tests are inconclusive because the sample was not usable, so only 269 out of 286 have results.
|
PRIMARY outcome
Timeframe: 90 DaysPopulation: Adolescent and young adult women with pelvic inflammatory disease (PID) in Baltimore City randomized to the intervention or control group and also had results for chlamydia (CT) and gonorrhea (GC) at 90 days after enrollment. All enrolled participants were followed as long as possible for entire 90 days.
STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).
Outcome measures
| Measure |
TECH-N
n=135 Participants
Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
Technology Enhanced Community Health Nursing: -Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)
-Enhanced community health nursing visit on day 3-5, includes DEBI STI/HIV prevention component (Sister to Sister Teen)
|
Control
n=125 Participants
Participants receive enhanced standard of care
|
|---|---|---|
|
Number of Participants With Positive Sexually Transmitted Infection Test (STI)
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: Chi-square test results from participants in the intervention and control groups who had data on adherence to treatment. Out of 149 enrolled in the intervention arm, 10 were lost to followup by 72 hours. Out of 137 enrolled in the control arm, 15 were lost by 72 hours and so are missing this outcome measure.
Completion of 72-hour assessment visit by medical provider, medication adherence (self-reported), partner notification, partner treatment, and temporary sexual abstinence
Outcome measures
| Measure |
TECH-N
n=139 Participants
Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
Technology Enhanced Community Health Nursing: -Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)
-Enhanced community health nursing visit on day 3-5, includes DEBI STI/HIV prevention component (Sister to Sister Teen)
|
Control
n=123 Participants
Participants receive enhanced standard of care
|
|---|---|---|
|
Number of Participants That Adhered to Self-treatment
|
131 Participants
|
20 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=149 participants at risk
Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
|
Control
n=137 participants at risk
Participants receive enhanced standard of care
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.67%
1/149 • Number of events 1 • Women were followed for adverse events for the primary study period of three months.
|
0.00%
0/137 • Women were followed for adverse events for the primary study period of three months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place