Please select the eligibility criteria that correspond to the clinical trial below.
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)
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.


Options:
A: Inclusion Criteria:

1. pregnant,
2. smoke or quit in the past 2 weeks,
3. has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts,
4. an English speaker.

Exclusion Criteria:

1. not pregnant
2. not currently smoking (or within past 2 weeks)
3. not able to receive text messages
4. not an English speaker
B: 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.
C: Inclusion Criteria:

* Living with HIV
* English speaking
* Have started antiretroviral therapy (ART) in the last three months or restarted ART in the last three months after not taking ART for approximately six months
* Have access to a smartphone for the duration of the study
* Not involved with another HIV prevention or adherence related study
* Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment
* Detectable viral load

Exclusion Criteria:

* None
D: Inclusion Criteria:

* Pregnant women age 18 to 40 years
* Singleton birth (e.g. no twins or triplets)
* Prenatal intention to breastfeed
* Have a mobile phone capable of receiving SMS text messages and phone calls
* Know how to send a text message
* ≥4th grade literacy level

Exclusion Criteria:

* Non-fluent in English
* Known fetal anomaly
* Infant delivery \<37 weeks
* \>3 days in neonatal intensive care unit (NICU)
* Medical history: pre-pregnancy BMI \>50, history of thyroid disorders, failed one hour and three hour glucola test or if they ever needed oral hypoglycemic, hypertension (HTN) before/during pregnancy, postpartum hemorrhage
* Medically contraindicated for breastfeeding (provider's judgment)
* Women who will breastfeed but not from their own breast (e.g. buy breast milk on the Internet/milk bank)
* Women who are hesitant about answering a series of text messages regularly
* Women who are unable to be contacted by SMS text message or are unwilling to provide their contact number
* Women with neurologic, anatomic, or cognitive disorders that are unable to consent and/or answer text messages

Answer: B