BACKGROUND:

Adolescent HIV patients face enormous difficulty in accessing HIV care services. Given their vulnerability to risk-taking behaviour, this group also have worse treatment outcomes compared to other age groups. Poor treatment outcomes will impact negatively on HIV/AIDS management and control particularly in sub-Saharan Africa (SSA) as more than eight out of ten of the world's HIV-infected adolescents live in this region of the world. Limited evidence exists on the effectiveness of service delivery interventions to support adolescents' retention on antiretroviral therapy (ART) and adherence to ART. This trial is designed to evaluate the impact of conditional economic incentive and motivational interviewing on adolescents' retention in HIV care and adherence to ART in Anambra State, Southeast Nigeria.

METHODS/DESIGN:

The study will be a cluster randomised controlled trial that will be conducted in selected HIV treatment hospitals in Anambra State, Nigeria. Based on sample size calculation, 12 HIV treatment hospitals from Anambra will be selected for the study. Six HIV treatment hospitals each will be randomised to either the intervention or the control arm. A structured adherence support scheme termed the 'Incentive Scheme' will be applied to the intervention arm while the control arm will receive routine HIV care (usual care). Additionally, patients in the intervention arm will receive motivational interviewing at baseline and following initiation of antiretroviral therapy (ART), they will receive a gift voucher of US$5.6 when HIV viral load (VL) is < 20 copies/mL at 12 weeks, a gift voucher of US$2.8 if the VL remains suppressed for the next 3 months, and the next 6 months, and finally a gift voucher of US$5.6 if the VL remains < 20 copies/mL at 1 year. All gift vouchers will be conditional not only on VL results but attending the motivational interviews. The primary outcome for the trial will be the difference between groups in the proportion with HIV VL suppression (≤ 20 copies/mL) by 12 months and then 24 months after withdrawal of incentive.

DISCUSSION:

The findings of this proposed trial will provide evidence on the feasibility of applying conditional economic incentives combined with motivational interviewing to improve retention and adherence to antiretroviral therapy of adolescents living with HIV in Nigeria and possibly in other sub-Saharan African countries.

TRIAL REGISTRATION:

Registered in the Pan African Clinical Trials Registry, ID: PACTR201806003040425 . Registered on 2 February 2018.

Background

In sub-Saharan Africa, there is increasing mortality and morbidity of adolescents due to poor linkage, retention in HIV care and adherence to antiretroviral therapy (ART). This is a result of limited adolescent-centred service delivery interventions. This cost-effectiveness and feasibility study were piggybacked on a cluster-randomized trial that assessed the impact of an adolescent-centred service delivery intervention. The service delivery intervention examined the impact of an incentive scheme consisting of conditional economic incentives and motivational interviewing on the health outcomes of adolescents living with HIV in Nigeria.

Method

A cost-effectiveness analysis from the healthcare provider’s perspective was performed to assess the cost per additional patient achieving undetected viral load through the proposed intervention. The cost-effectiveness of the incentive scheme over routine care was estimated using the incremental cost-effectiveness ratio (ICER), expressed as cost/patient who achieved an undetectable viral load. We performed a univariate sensitivity analysis to examine the effect of key parameters on the ICER. An in-depth interview was conducted on the healthcare personnel in the intervention arm to explore the feasibility of implementing the service delivery intervention in HIV treatment hospitals in Nigeria.

Result

The ICER of the Incentive Scheme intervention compared to routine care was US$1419 per additional patient with undetectable viral load. Going by the cost-effectiveness threshold of US$1137 per quality-adjusted life-years suggested by Woods et al., 2016, the intervention was not cost-effective. The sensitivity test showed that the intervention will be cost-effective if the frequency of CD4 count and viral load tests are reduced from quarterly to triannually. Healthcare professionals reported that patients’ acceptance of the intervention was very high.

Conclusion

The conditional economic incentives and motivational interviewing was not cost-effective, but can become cost-effective if the frequency of HIV quality of life indicator tests are performed 1–3 times per annum. Patients’ acceptance of the intervention was very high. However, healthcare professionals believed that sustaining the intervention may be difficult unless factors such as government commitment and healthcare provider diligence are duly addressed.

Trial registration

This trial is registered in the WHO International Clinical Trials Registry through the WHO International Registry Network (PACTR201806003040425).

Background

Adolescents living with HIV (ALHIV) have had worse outcomes compared to adults. They face enormous difficulty in accessing HIV care services. We hypothesize that conditional economic incentives (CEI) and motivational interviewing could increase retention in care, medication adherence and ultimately viral load suppression. Therefore, we evaluated the one-year impact of conditional economic incentives and motivational interviewing on the health outcomes of ALHIV in Anambra State, Nigeria.

Methods

Using a cluster-randomised design, we examined the one-year (from December 1, 2018, to November 30, 2019), individual-level impact of an Incentive Scheme comprising conditional economic incentives and motivational interviewing on achieving undetectable viral load (primary outcome), CD4⁺ count, adherence to antiretroviral therapy and retention in care (secondary outcomes) by ALHIV in Anambra State, Nigeria. Twelve HIV treatment hospitals were stratified according to the type of clinic (secondary or tertiary) and randomly assigned to the intervention arm or control arm to receive the Incentive Scheme or routine care, respectively. ALHIV aged 10–19 years, initiated into HIV care for a minimum of 6 months, and who adhered poorly to medications (<100% adherence rate) were eligible for the study. Participants in the intervention arm received motivational interviewing at the study baseline and every visit. They also received US$5.6 when HIV viral load (VL) was <20 copies/mL at month 3, US$2.8 if the VL remained suppressed at months 6 and 9, and US$5.6 if the VL remained <20 copies/mL at month 12.

Results

Of the 246 trial participants, 119 were in the intervention while 127 were in the control arm. There was no difference in the baseline characteristics of the participants between the intervention and control arm except for the number of participants with undetectable viral load and the number of participants with ≥95% adherence. Although participants in the intervention arm had a 10.1% increase while those in the control arm had a 1.6% decrease in proportion with undetectable viral load (≤20 copies/ml) after 12 months, the change in the primary outcome was not statistically significant. Similarly, the differences in the secondary outcomes were not statistically significant.

Conclusion

The Incentive Scheme did not improve the virologic outcome of ALHIV after 12 months. Differences in the secondary outcomes after 12 months were also not significantly different from the baseline.

Trial registration

We registered the trial retrospectively with The Pan African Clinical Trials Registry: https://pactr.samrc.ac.za/(PACTR201806003040425) on 2/2/2018.