HIV Infections Clinical Trial
— STARTAOfficial title:
A Single-blind, Randomized, Parallel Design Study to Assess the Effectiveness of SMS Reminders in Improving ART Adherence Among Adolescents Living With HIV in Nigeria (STARTA Trial-Adolescents)
Verified date | November 2019 |
Source | Babcock University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The non-maintenance of ART adherence is a major barrier to the achievement of optimal
treatment outcomes among adolescents living with HIV. ART adherence is a challenge among
adolescents living with HIV because of lack of appropriate information, their unique
emotional state and lifestyles but the most commonly quoted challenge to adherence is
forgetting to take antiretroviral drugs. There is evidence to suggest that short message
service (SMS) reminder- interventions may enhance drug compliance among adolescents living
with other chronic diseases such as asthma and diabetes. Available literature underscores the
need for randomized controlled trials (RCTs) of effective interventions to promote ART
adherence among adolescents with HIV.
The aim of this study is to evaluate the feasibility, acceptability, and efficacy of
interactive and tailored SMS reminders on ART adherence among adolescents (15-19 years)
living with HIV in Ogun State, Nigeria. The study hypothesizes that the use of personal
mobile phones and SMS reminders for the improvement of ART adherence among adolescents living
with HIV are feasible, acceptable, and effective.
A single-blind, parallel-design (ratio 1:1), and multi-center RCT of 230 adolescent living
with HIV who are non-adherent to medications will be conducted over a one-year period in
Southwest Nigeria. All the participants will receive routine adherence counseling during
clinic visits and one SMS reminder each for follow-up appointments 48 hours and 24 hours
before the follow-up visit date. The intervention group will also receive daily ART adherence
reminder SMS. Participants will be assessed at baseline and during follow-up visits at 4, 8,
12, 16 and 20 weeks after the baseline. Baseline assessment of participants will include
socio-demographic characteristics; HIV/AIDS risk behaviour assessment, Alcohol and Drug abuse
assessment, Client Satisfaction Survey, ART adherence assessment, CD4count and viral load
assessments. ART adherence and client satisfaction will be assessed at each follow-up visit
while CD4count and viral load assessments will be done at baseline and at 20th week.
It is possible that tailored SMS reminders will mitigate the barrier of forgetfulness in
ART-adherence and lead to improved drug compliance, viral suppression, and quality of life
among adolescents living with HIV.
Status | Completed |
Enrollment | 212 |
Est. completion date | June 30, 2019 |
Est. primary completion date | May 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 19 Years |
Eligibility |
Inclusion Criteria: - HIV seropositivity - Being on ART for at least three month - Age 15 to 19 years as at last birthday - Use of personal mobile phone - Poor adherence to ART Exclusion Criteria: Adolescents who are too ill to require hospital admission will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Nigeria | Federal Medical Center | Abeokuta | Ogun State |
Nigeria | State Hospital | Ijebu-Ode | Ogun State |
Nigeria | Lagos State University Teaching Hospital | Ikeja | Lagos |
Nigeria | State Hospital | Ota | Ogun State |
Nigeria | The Nigerian Institute of Medical Research | Yaba | Lagos |
Lead Sponsor | Collaborator |
---|---|
Dr. Olumide ABIODUN |
Nigeria,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ART Adherence at 20 Weeks as Determined by VAS, Viral Load | 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. |
20week [End of study] | |
Primary | ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores | 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 |
20week [End of study] | |
Primary | ART Adherence at 20 Weeks as Determined by Viral Load Count | 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 | 20 week [End of study] | |
Primary | ART Adherence at 20 Weeks as Determined by Log of Viral Load Count | log of viral load count is log 10 transformation of the viral load values | 20week [End of study] | |
Secondary | Patient Satisfaction Score at 20 Weeks | 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. | End of Study (20weeks) | |
Secondary | Number of Participants With Mental Distress Determined by General Health Questionnaire 12 at 20 Weeks | 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. | End of study (20weeks) |
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