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

NCT03394391 | Completed Results

• 2 other identifiers: BUTH/CT/0001MISP Database number #57473
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 5

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 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.

Conditions

HIV Infections

Keywords

Adherence; Adolescents; Antiretroviral therapy; HIV; Nigeria; Randomized controlled trial; Short message services

Outcome Measures

Primary Outcomes (4)

• 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]

• 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]

• 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]

• 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 Outcomes (2)

• Patient Satisfaction Score at 20 Weeks

  End of Study (20weeks)

• Number of Participants With Mental Distress Determined by General Health Questionnaire 12 at 20 Weeks

  End of study (20weeks)

Study Arms (2)

Intervention group

EXPERIMENTAL

Daily ART-adherence SMS reminder

Behavioral: Daily ART-adherence SMS reminder; Behavioral: Standard Adherence Counselling/Patient experience group chat

Control group

ACTIVE COMPARATOR

Standard adherence counselling/Patient experience group chat

Behavioral: Standard Adherence Counselling/Patient experience group chat

Interventions

Daily ART-adherence SMS reminder BEHAVIORAL

Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.

Intervention group

Standard Adherence Counselling/Patient experience group chat BEHAVIORAL

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.

Control group; Intervention group

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Adolescents who are too ill to require hospital admission will be excluded from the study.

Sponsors & Collaborators

• Dr. Olumide ABIODUN: lead

Study Sites (5)

Lagos State University Teaching Hospital

Ikeja, Lagos, Nigeria

Location

The Nigerian Institute of Medical Research

Yaba, Lagos, Nigeria

Location

Federal Medical Center

Abeokuta, Ogun State, Nigeria

Location

State Hospital

Ijebu Ode, Ogun State, Nigeria

Location

State Hospital

Ota, Ogun State, Nigeria

Location

Related Publications (28)

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  BACKGROUND

• Abiodun O, Jagun O, Sodeinde K, Bamidele F, Adekunle M, David A. Socioeconomic, clinical, and behavioral characteristics of adolescents living with HIV in Southwest Nigeria: implication for preparedness for transition to adult care. AIDS Care. 2022 Mar;34(3):315-323. doi: 10.1080/09540121.2021.1906402. Epub 2021 Mar 25.

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• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

  PMID: 32779730 DERIVED

Related Links

• AIDSInfo for Nigeria
• Nigeria's Phone subscribers increase to 152.1 million
• AIDS Law Brief; Age of Consent for HIV Testing and Counseling in Nigeria
• Drug Abuse Screening Test (DAST) - Adolescent Version
• ACTG Adherence Baseline and Follow up Questionnaires
• ADOLESCENT HIV TESTING, COUNSELLING AND CARE Implementation guidance for health providers and planners
• Teens and Mobile Phones
• The Alcohol Use Disorders Identification Test: Interview version
• Is a simple self-rating or visual analogue scale more accurate than prescription refill data, as an indicator of non-adherence in a resource-limited setting in South Africa?

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Olumide ABIODUN
• Organization: Babcock University

olumiabiodun@gmail.com

07038569725

Study Officials

• Olumide ABIODUN, FWACP

  Babcock University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer and Honorary Consultant

Model Details: A single-blind, parallel-design (ratio 1:1), and multi-centre RCT of 230 adolescent living with HIV who are non-adherent to medications will be conducted over a one-year period in Southwest Nigeria.

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 9, 2018
• Study Start: July 5, 2018
• Primary Completion: May 3, 2019
• Study Completion: June 30, 2019
• Last Updated: November 15, 2019
• Results First Posted: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: June 30th, 2019 to June 29th, 2020
• Access Criteria: Open access Other information will be available upon reasonable request

Locations

NG (5)