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Trial record 9 of 66 for:    "quality of life" AND "HIV infections " [CONDITION ] | Recruiting, Not yet recruiting, Available Studies

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 : Not yet recruiting
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Olumide ABIODUN, Babcock University

Brief Summary:

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 200 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 8 and 16 weeks.

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.


Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Daily ART-adherence SMS reminder Behavioral: Standard Adherence Counselling/Patient experience group chat Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single-blind, parallel-design (ratio 1:1), and multi-centre RCT of 200 adolescent living with HIV who are non-adherent to medications will be conducted over a one-year period in Southwest Nigeria.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The investigators, data manager, research assistants, counselors and other project staff will be blinded throughout the study. An independent medical internet technology firm will be contracted to randomize participants and to send the required SMS to the participants. After scientific review has been completed and data collection has been completed, at the point of analysis, a list of participants' unique identifiers in two groups will be sent to the data analysts without specifying which the investigation or control group is. The blinding of the clinical database will finally be removed after final data analysis has been completed.
Primary Purpose: Supportive Care
Official 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)
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention group
Daily ART-adherence SMS reminder
Behavioral: 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.

Behavioral: 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.


Active Comparator: Control group
Standard adherence counselling/Patient experience group chat
Behavioral: 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.





Primary Outcome Measures :
  1. Change in ART adherence status [ Time Frame: Baseline (week 0), 4weeks, 8weeks, 12weeks, 16weeks, 20weeks ]

    ART adherence is assessed by different well-validated methods. In this study, ART adherence will be measured, primarily, using the self-report visual analogue 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.

    Pill count, pharmacy record, and the AIDS Clinical Trials Group (ACTG) adherence questionnaire will also be used to assess adherence in order to correlate the findings of the various methods among adolescents.



Secondary Outcome Measures :
  1. Change in level of patient satisfaction [ Time Frame: Baseline (week 0), 4weeks, 8weeks, 12weeks, 16weeks, 20weeks ]
    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.

  2. Change in mental health status [ Time Frame: Baseline (week 0), 4weeks, 8weeks, 12weeks, 16weeks, 20weeks ]
    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.



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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV seropositivity
  • Being on ART for at least one 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394391


Contacts
Contact: Olumide ABIODUN, FWACP +2347038569725 abioduno@babcock.ed.ng

Locations
Nigeria
Babcock University Teaching Hospital Not yet recruiting
Ilishan, Ogun State, Nigeria
Contact: ART Clinic Physician    +2347038569725    olumiabiodun@gmail.com   
Contact: , FWACS         
Sponsors and Collaborators
Dr. Olumide ABIODUN
Investigators
Principal Investigator: Olumide ABIODUN, FWACP Babcock University

Additional Information:
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

Responsible Party: Dr. Olumide ABIODUN, Senior Lecturer and Honorary Consultant, 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 Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Olumide ABIODUN, Babcock University:
Adherence
Adolescents
Antiretroviral therapy
HIV
Nigeria
Randomized controlled trial
Short message services

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases