Improving Clinic Attendance for Medication Collection Among HIV Positive Individuals in Nepal

NCT03367130 | Completed

• 1 other identifier: 11711
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From 2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. However, ART's success heavily depends on HIV-positive individuals' high adherence to it. This includes clinic attendance for various purposes. It is necessary among HIV-positive individuals for their antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART clinic attendance. Improving clinic attendance for pills pick up remains one of the key challenges to ART programs. The World Health Organization (WHO) recommends more than 90% on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. Among six Asian countries, none of the 1048 clinics under the study could meet the WHO target. Among HIV-positive individuals, clinic attendance for pills pick can be improved by using mobile phones. Those who receive mobile phone reminders are two times more likely to attend their clinics regularly than those who did not receive such reminders. Nepal belongs to a low-income country and is facing a similar problem, too. In 2015, approximately 39,000 people were estimated to be living with HIV and ART coverage was limited to only 31.5%. In the same year, only 32% of the HIV-positive individuals attended their clinics regularly for ARV pills pick up. Like other countries, one of the potential strategies is to use mobile phones effectively in Nepal. Mobile phones have been very widely used in Nepal. In 2016, Nepal had 27.9 million mobile phone users, against the population of 26.5 million. Under such a context, mobile phone reminders can be effective to improve clinic attendance among HIV-positive individuals. However, the effectiveness of such interventions barely remains examined by using a randomized controlled trial. This study evaluates the effectiveness of mobile phone reminder intervention on improving clinic attendance for ARV pills pick up and medication adherence among HIV-positive individuals on ART following the implementation of test and treat strategy in Nepal.

Conditions

HIV Infections; Antiretroviral Therapy; HIV Seropositivity

Keywords

Antiretroviral therapy, clinic attendance, Nepal

Outcome Measures

Primary Outcomes (1)

• Clinic attendance for pills pick up

  Clinic attendance adherence rate will be used to assess the clinic attendance. The rate will be based on the rate of total days adhered to the total scheduled days. An attendance will be called 'adhered', when they maintained an attendance in less than or equals to two days among scheduled days. Information on clinic attendance will be obtained from HIV-positive individuals' treatment and care files. Clinic attendance will be measured over the period of six months after the intervention. Dichotomous measure will be used to assess the clinic attendance for pills pick up. A 100% adherence rate will be used to define regular clinic attendance and missing any appointment(s) will be categorized as inconsistent clinic attendance.

  six months.

Secondary Outcomes (2)

• Delay in pills pick up

  Six months.

• Medication adherence

  Six months.

Study Arms (2)

Intervention

EXPERIMENTAL

HIV-positive individuals will receive the standard HIV care following the national ART guidelines. In addition, the intervention group will receive mobile phone calls. A mobile phone reminder will be made two days prior to their scheduled appointment for pills pick up. Trained research assistants will remind them of their scheduled clinic appointment of pills pick up. If the first call is missed, the second call will be made within the same day, if the second call is also missed, the final call will be made next day. The intervention will be delivered over the period of six months. Outcome assessors will not be involved in the phone calls.

Behavioral: Mobile phone reminder

Control

PLACEBO COMPARATOR

Control group will also receive the standard HIV care following the national ART guidelines and phone calls educating them on healthy living. Phone calls will be made once a month.

Behavioral: Mobile phone reminder

Interventions

Mobile phone reminder BEHAVIORAL

Intervention described already in arm/group descriptions.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility criteria
• be 18 years or over;
• own a mobile phone;
• started treatment following test and treat strategy; and
• under the first line ART regimen

Sponsors & Collaborators

• Tokyo University: lead
• Asian Development Bank Japan Scholarship Program: collaborator
• Open Society Institute: collaborator

Study Sites (1)

Seti Zonal Hospital

Dhangadi, State 7., Nepal

Location

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MeSH Terms

Conditions

HIV Infections; HIV Seropositivity

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

Study Officials

• Masamine Jimba, PhD, MD, MPH

  Tokyo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study will be a double blinded RCT. HIV-positive individuals will be blinded to allocation group. Further, those who deliver the intervention will be blinded to the allocation. Intervention and control groups will receive similar intervention strategies. Only the content of the interventions will be different. Therefore, it is difficult for HIV-positive individuals to tell if they are receiving intervention or control. The outcome assessor will be masked to the allocation of each HIV-positive individual by using trial identity numbers. Only the principal researcher will have complete access to all the information.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 8, 2017
• Study Start: October 14, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)