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Trial record 53 of 666 for:    SMS

The Effectiveness of SMS in Improving Antiretroviral Medication Adherence Among Adolescents Living With HIV in Nigeria (STARTA)

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ClinicalTrials.gov Identifier: NCT03394391
Recruitment Status : Completed
First Posted : January 9, 2018
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Olumide ABIODUN, Babcock University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition HIV Infections
Interventions Behavioral: Daily ART-adherence SMS reminder
Behavioral: Standard Adherence Counselling/Patient experience group chat
Enrollment 212
Recruitment Details Participants were recruited while attending routine clinic visits across five (5) high patient-density ART sites in 2 States in South West, Nigeria over a 13 week period.
Pre-assignment Details There was no significant event.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Period Title: Overall Study
Started 106 106
Completed 105 104
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
Arm/Group Title Intervention Group Control Group Total
Hide Arm/Group Description

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Total of all reporting groups
Overall Number of Baseline Participants 106 106 212
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 106 participants 212 participants
16.56  (1.41) 16.66  (1.36) 16.61  (1.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 106 participants 212 participants
Female
51
  48.1%
53
  50.0%
104
  49.1%
Male
55
  51.9%
53
  50.0%
108
  50.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 106 participants 212 participants
Yoruba
67
  63.2%
67
  63.2%
134
  63.2%
Hausa
3
   2.8%
2
   1.9%
5
   2.4%
Igbo
24
  22.6%
26
  24.5%
50
  23.6%
Others
12
  11.3%
11
  10.4%
23
  10.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Nigeria Number Analyzed 106 participants 106 participants 212 participants
106 106 212
Baseline ART Adherence (VAS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 106 participants 212 participants
VAS adherence (Self report of >/=95% adherence)
0
   0.0%
0
   0.0%
0
   0.0%
Viral Load </= 20
54
  50.9%
49
  46.2%
103
  48.6%
[1]
Measure Description:

VAS Adherence is the self-report of ART adherence using the visual analog scale. Participants reporting adherence of >/=95% have optimal adherence to the medications.

Viral load is the number of copies of viral RNA detected in participants' blood. Participants with viral load </=20 copies per ml are regarded to have optimal viral suppression indicative of optimal adherence to medications.

1.Primary Outcome
Title ART Adherence at 20 Weeks as Determined by VAS, Viral Load
Hide Description

ART adherence is assessed by different well-validated methods. In this study, ART adherence will be measured, primarily, using the self-report visual analog scale. The scale is well-validated, self-report of the level of ART adherence with a range from 0 to 100%. While higher values indicate better levels of adherence, patients with adherence levels of 95% and above are regarded as ART-adherent while those with values less than 95% are not adherent to ART medications.

Viral load is the number of copies of viral RNA detected in participants' blood. Participants with viral load </=20 copies per ml are regarded to have optimal viral suppression indicative of optimal adherence to medications.

Time Frame 20week [End of study]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Overall Number of Participants Analyzed 105 104
Measure Type: Count of Participants
Unit of Measure: Participants
Adherence by VAS
57
  54.3%
47
  45.2%
Viral Load </= 20 copies
63
  60.0%
46
  44.2%
2.Primary Outcome
Title ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores
Hide Description

AIDS Clinical Trials Group Scale scores range from 0 to 1. The higher scores reflect better ART adherence Pill count scores also range from 0 to 1 and the higher scores also reflect better adherence.

Visual analog scale [VAS] adherence ranges between 0 and 100%. Higher scores reflect better ART adherence

Time Frame 20week [End of study]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Overall Number of Participants Analyzed 105 104
Mean (Standard Deviation)
Unit of Measure: measurement vlaues and score on a scale
AIDS Clinical Trials Group Scale score 0.92  (0.15) 0.90  (0.17)
Pill count score score 0.68  (0.24) 0.65  (0.28)
VAS score, continuous 89.04  (11.90) 86.99  (13.50)
3.Primary Outcome
Title ART Adherence at 20 Weeks as Determined by Viral Load Count
Hide Description Viral load count is measured in copies per ml. The minimum value is 0. There is no maximum value. The higher values reflect poor adherence
Time Frame 20 week [End of study]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Overall Number of Participants Analyzed 105 104
Mean (Standard Deviation)
Unit of Measure: copies/mL
11678  (51003.77) 42676.71  (147790.6)
4.Primary Outcome
Title ART Adherence at 20 Weeks as Determined by Log of Viral Load Count
Hide Description log of viral load count is log 10 transformation of the viral load values
Time Frame 20week [End of study]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Overall Number of Participants Analyzed 105 104
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.97  (1.30) 2.63  (1.55)
5.Secondary Outcome
Title Patient Satisfaction Score at 20 Weeks
Hide Description Patient satisfaction will be assessed using a 22-item adaptation of the SERVQUAL tool. It is a multi-dimensional service quality assessment tool that uses a 5-point likert scale scored from 1 to 5 points to assess 5 domains of client satisfaction. The domains are tangibility (4 items; scores from 4 to 20), reliability (5 items; scores from 5 to 25), responsiveness (4 items; scores from 4 to 20), assurance (4 items; scores from 4 to 20), and empathy (5 items; scores from 5 to 25). Patient satisfaction is measured by the total score which will range between 22 and 110. Higher scores indicate better client satisfaction.
Time Frame End of Study (20weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Overall Number of Participants Analyzed 105 104
Mean (Standard Deviation)
Unit of Measure: score on a scale
88.94  (9.26) 91.76  (8.72)
6.Secondary Outcome
Title Number of Participants With Mental Distress Determined by General Health Questionnaire 12 at 20 Weeks
Hide Description The General Health Questionnaire 12 (GHQ12) will be used to assess the mental health status of all the participants. It is a well-validated and widely used instrument for screening for mental health distress. It is a 12-item questionnaire that is based on a 4-point likert scale scored from 0 to 3 points. The scores will range between 0 and 36. A score of 12 or more is suggestive of mental distress while scores less than 12 suggest that mental distress is absent.
Time Frame End of study (20weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Overall Number of Participants Analyzed 105 104
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.9%
11
  10.6%
Time Frame 20 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

Daily ART-adherence SMS reminder

Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

Standard adherence counselling/Patient experience group chat

Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.

All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges.

All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/106 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/106 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/106 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Olumide ABIODUN
Organization: Babcock University
Phone: 07038569725 ext 7038569725
EMail: olumiabiodun@gmail.com
Publications:
Shacham E, Estlund A, Presti R. Viral suppression among young adults in a US outpatient clinic. BMC Infectious Diseases 14(Suppl 2): P76, 2014. https://doi.org/10.1186/1471-2334-14-S2-P76
Layout table for additonal information
Responsible Party: Dr. Olumide ABIODUN, Babcock University
ClinicalTrials.gov Identifier: NCT03394391     History of Changes
Other Study ID Numbers: BUTH/CT/0001
MISP Database number #57473 ( Other Grant/Funding Number: MERCK SHARP & DOHME CORP. )
First Submitted: December 28, 2017
First Posted: January 9, 2018
Results First Submitted: September 14, 2019
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019