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,
Bam K, Rajbhandari RM, Karmacharya DB, Dixit SM. Strengthening adherence to Anti Retroviral Therapy (ART) monitoring and support: operation research to identify barriers and facilitators in Nepal. BMC Health Serv Res. 2015 May 5;15:188. doi: 10.1186/s12913-015-0846-8. — View Citation
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18. — View Citation
Cole-Lewis H, Kershaw T. Text messaging as a tool for behavior change in disease prevention and management. Epidemiol Rev. 2010;32:56-69. doi: 10.1093/epirev/mxq004. Epub 2010 Mar 30. Review. — View Citation
Donenberg GR, Schwartz RM, Emerson E, Wilson HW, Bryant FB, Coleman G. Applying a cognitive-behavioral model of HIV risk to youths in psychiatric care. AIDS Educ Prev. 2005 Jun;17(3):200-16. — View Citation
Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R. Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res. 2012 Apr 5;14(2):e51. doi: 10.2196/jmir.2015. — View Citation
Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040. Review. — View Citation
Franklin VL, Waller A, Pagliari C, Greene SA. A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. Diabet Med. 2006 Dec;23(12):1332-8. — View Citation
Giordano TP, Guzman D, Clark R, Charlebois ED, Bangsberg DR. Measuring adherence to antiretroviral therapy in a diverse population using a visual analogue scale. HIV Clin Trials. 2004 Mar-Apr;5(2):74-9. — View Citation
Glikman D, Walsh L, Valkenburg J, Mangat PD, Marcinak JF. Hospital-based directly observed therapy for HIV-infected children and adolescents to assess adherence to antiretroviral medications. Pediatrics. 2007 May;119(5):e1142-8. Epub 2007 Apr 23. — View Citation
Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28. Review. — View Citation
Horvath T, Azman H, Kennedy GE, Rutherford GW. Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD009756. doi: 10.1002/14651858.CD009756. Review. — View Citation
Hung SH, Tseng HC, Tsai WH, Lin HH, Cheng JH, Chang YM. Care for Asthma via Mobile Phone (CAMP). Stud Health Technol Inform. 2007;126:137-43. — View Citation
Kalichman SC, Amaral CM, Swetzes C, Jones M, Macy R, Kalichman MO, Cherry C. A simple single-item rating scale to measure medication adherence: further evidence for convergent validity. J Int Assoc Physicians AIDS Care (Chic). 2009 Nov-Dec;8(6):367-74. doi: 10.1177/1545109709352884. — View Citation
Kalichman SC, Kalichman MO, Cherry C, Swetzes C, Amaral CM, White D, Jones M, Grebler T, Eaton L. Brief behavioral self-regulation counseling for HIV treatment adherence delivered by cell phone: an initial test of concept trial. AIDS Patient Care STDS. 2011 May;25(5):303-10. doi: 10.1089/apc.2010.0367. Epub 2011 Apr 2. — View Citation
Lester RT, Mills EJ, Kariri A, Ritvo P, Chung M, Jack W, Habyarimana J, Karanja S, Barasa S, Nguti R, Estambale B, Ngugi E, Ball TB, Thabane L, Kimani J, Gelmon L, Ackers M, Plummer FA. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol. Trials. 2009 Sep 22;10:87. doi: 10.1186/1745-6215-10-87. — View Citation
McMahon JH, Elliott JH, Bertagnolio S, Kubiak R, Jordan MR. Viral suppression after 12 months of antiretroviral therapy in low- and middle-income countries: a systematic review. Bull World Health Organ. 2013 May 1;91(5):377-385E. doi: 10.2471/BLT.12.112946. Epub 2013 Feb 21. Review. — View Citation
Miloh T, Annunziato R, Arnon R, Warshaw J, Parkar S, Suchy FJ, Iyer K, Kerkar N. Improved adherence and outcomes for pediatric liver transplant recipients by using text messaging. Pediatrics. 2009 Nov;124(5):e844-50. doi: 10.1542/peds.2009-0415. Epub 2009 Oct 12. — View Citation
Montazeri A, Harirchi AM, Shariati M, Garmaroudi G, Ebadi M, Fateh A. The 12-item General Health Questionnaire (GHQ-12): translation and validation study of the Iranian version. Health Qual Life Outcomes. 2003 Nov 13;1:66. — View Citation
Naar-King S, Templin T, Wright K, Frey M, Parsons JT, Lam P. Psychosocial factors and medication adherence in HIV-positive youth. AIDS Patient Care STDS. 2006 Jan;20(1):44-7. — View Citation
Nugent NR, Brown LK, Belzer M, Harper GW, Nachman S, Naar-King S; Adolescent Trials Network for HIV/AIDS Interventions. Youth living with HIV and problem substance use: elevated distress is associated with nonadherence and sexual risk. J Int Assoc Physicians AIDS Care (Chic). 2010 Mar-Apr;9(2):113-5. doi: 10.1177/1545109709357472. Epub 2010 Feb 4. — View Citation
Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, MacKeen L, Haberer J, Kimaiyo S, Sidle J, Ngare D, Bangsberg DR. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011 Mar 27;25(6):825-34. doi: 10.1097/QAD.0b013e32834380c1. — View Citation
Purdy JB, Freeman AF, Martin SC, Ryder C, Elliott-DeSorbo DK, Zeichner S, Hazra R. Virologic response using directly observed therapy in adolescents with HIV: an adherence tool. J Assoc Nurses AIDS Care. 2008 Mar-Apr;19(2):158-65. doi: 10.1016/j.jana.2007.08.003. Review. — View Citation
Rao D, Kekwaletswe TC, Hosek S, Martinez J, Rodriguez F. Stigma and social barriers to medication adherence with urban youth living with HIV. AIDS Care. 2007 Jan;19(1):28-33. — View Citation
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
Watt MH, Maman S, Golin CE, Earp JA, Eng E, Bangdiwala SI, Jacobson M. Factors associated with self-reported adherence to antiretroviral therapy in a Tanzanian setting. AIDS Care. 2010 Mar;22(3):381-9. doi: 10.1080/09540120903193708. — View Citation
Wei J, Hollin I, Kachnowski S. A review of the use of mobile phone text messaging in clinical and healthy behaviour interventions. J Telemed Telecare. 2011;17(1):41-8. doi: 10.1258/jtt.2010.100322. Epub 2010 Nov 19. Review. — View Citation
* 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |