Review question/objective

The objective of this review is to determine the effectiveness of counseling, material support and/or nutritional supplementation on improving adherence to anti-retroviral therapy (ART) and clinical outcomes among HIV patients

Background

The HIV/AIDS epidemic is truly global with 186 countries reporting HIV cases or deaths in 2012.1,2 According to the UNAIDS World AIDS Day Report 2012, a total of 34 million people were living with HIV in 2011. Of the 34 million, 3.3 million were children under 15 years and 16.7 million were women.3 In 2012, 9.7 million HIV-positive people received ARTs, representing 61% of all eligible people in low- and middle-income countries.4 Worldwide more than 65 million people have been infected with HIV and 30 million people have died due to AIDS related causes since the emergence of AIDS in 1981.3 From 1980 to 2006, deaths from HIV/AIDS increased dramatically, peaking in 2006 where the annual rate of in global mortality was 19.4%.5 Since 2006, global HIV/AIDS mortality has gradually declined, with an average annual rate of 4.17%.5 The decline in HIV/AIDS mortality and incidence has been largely due to the rapid uptake of ART in some countries with large epidemics.6 Anti-retroviral therapy has changed HIV infection from a fatal disease to a chronic illness which can be managed, much like other chronic illnesses.7 However, multiple issues have been identified which may affect adherence to ART, including patient factors such as depression, substance abuse and treatment beliefs. Also, treatment factors such as regimen complexity, side effects and contextual factors have been identified to affect ART adherence.7

In 2010, it was estimated that HIV accounted for 2.8% of global deaths and 3.3% of global Disability Adjusted Life Years (DALYs).5 In spite of the recent decline in global mortality from HIV/AIDS, HIV/AIDS today remains one of the leading causes of both global mortality and burden.5

High adherence to ART is a key determinant of the degree and durability of viral suppression8 and has been associated with lower rates of disease progression, hospitalization and mortality.9 In contrast, poor adherence correlates with treatment failure8 and can limit options for future antiretroviral therapies due to cross-resistance between HIV drugs10 (HIV variants resistant to one drug in a class of antiretroviral drugs may be resistant to another drug in the same class). Thus, even brief periods of non-adherence to ART can have lifelong implications.10

Unfortunately, not all segments of the population living with HIV benefit equally from treatment. In San Francisco, only about 30% of the HIV-infected urban poor take a combination highly active antiretroviral medications11 as compared with 88% of HIV-infected gay men.12 Most homeless persons do not have food available to them on a consistent schedule. Therefore, they may have difficulty adhering to instructions to take medications only on an empty stomach or with food.12 Also, a study done in the northern part of Ethiopia showed that insufficient and low quality of food was associated with non-adherence to ART.13 Similarly, food insecurity was associated with poor ART adherence, decreased CD4 cell count, poor virologic suppression and decreased survival.14

Lack of a safe place to store medications may be another issue for some. In addition, many poor people in urban areas live with drug, alcohol or mental health problems, which can interfere with taking medications as prescribed.12 The homeless and marginally housed ("urban poor") living with HIV are less likely than other populations of HIV-infected people to be prescribed highly active antiretroviral medications and therefore are less likely to benefit from advances in HIV treatment. The competing life priorities of people living with the extremes of poverty, such as unstable housing, mental health problems and drug addiction, often make it difficult for the urban poor to adhere to complex medication regimens.12

Limited evidence suggests that interventions to improve adherence are most likely to be successful when they are comprehensive (in terms of cognitive, behavioral, emotional and social aspects) and tailored to the individual.15,16 A randomized controlled trial conducted in France among people living with HIV in 1999 showed that counseling interventions like cognitive behavioral therapy, motivational interviewing and medication management strategies are effective in increasing adherence to ART. Also, individual or group counseling and interventions of more than 12 weeks were associated with improved adherence to ART.17 A recent randomized controlled trial also indicated that three months' lipid based nutrient supplementation at the start of ART improved weight, lean body mass and grip strength. Also, food containing whey was identified to improve immune recovery.18 Another pilot study conducted in Zambia indicated that food supplementation was associated with better adherence to antiretroviral therapy.19 The same study indicated that there was no significant effect of food supplementation on clinical outcomes of patients with HIV.19 A primary study indicated that material support such as food and financial support improved adherence to ART.9

In order to demonstrate consistency of findings across these primary studies and to provide summarized evidence, the results of these studies should be synthesized so the resulting evidence can inform policy for the best effective interventions to improve the clinical outcomes of HIV patients. A preliminary search for systematic reviews on this topic was performed in PubMed, CINAHL, DARE and PROSPERO. No existing systematic reviews that reported on the effectiveness of counseling, nutritional support, provision of financial or material support (such as clothes) were identified in these databases.

Therefore, this systematic review will seek out the best available evidence regarding the effectiveness of counseling, material support and nutritional supplementation on improving adherence to ART, clinical outcomes and mortality among HIV patients.

Inclusion criteria

Types of participants

The review will consider studies that include HIV-positive patients aged 18 or above.

Types of intervention(s)/phenomena of interest

This review will consider studies that include counseling, nutritional support and financial or material support such as clothes to improve adherence to ART medication. Counseling is defined as advice given to a client to support them in their adherence to their medication regimen (e.g. ART treatment, cognitive behavioral therapy (CBT) and interpersonal psychotherapy (IPT) and to their care plan, including routine appointments). The counselor focuses on how to use the drug, and possible adverse effects and drug interactions. Incentive provision may include material, nutritional or social support. Nutritional support is providing important food which is rich with different nutrients. Material support is providing food, clothes and financial support. Depending on the studies, found comparisons may be made across each type of incentive.

Type of comparator

The comparator groups for the review will be those clients who have not been provided with counseling, material support and/or nutritional supplementation.

Types of outcomes

This review will consider studies that include the following outcome measures:

a. Adherence: Adherence to ART is the act of taking ART as prescribed and involves steady devotion and acceptance of taking medication in the correct amount, at the correct time and in the way prescribed. Adherence may be categorized as adhered (>=95% adherence over the previous 30 days and 100% adherence over the previous three days or the actual proportion of doses taken versus doses prescribed) or not adhered. Adherence can also be measured as improved (measured as a continuous scale) or not improved. Studies measuring adherence on continuous scales, if any, will also be considered.

b. Clinical outcome: This outcome may be measured by viral load, clinical staging, CD4 count, lean body mass or body mass index.

c. Mortality

Types of studies

This review will consider both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental studies, before and after studies, prospective and retrospective cohort studies, case control studies and analytical cross sectional studies conducted on effect of counseling and incentive provision on adherence to ART. Studies published in the English language will be considered for inclusion in this review without any limitation of publication date.

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies.

The databases to be searched include: MEDLINE, EMBASE, Web of Science and CINAHL.

The search for unpublished studies will include: MedNar, and ProQuest.

Initial keywords to be used will be: counseling, antiretroviral therapy, support, financial support, material support, adherence, ART, nutrition, supplementation and incentive.

Assessment of methodological quality

Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Data extraction

Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. The authors of primary studies will be contacted by e-mail if there is incomplete information.

Data synthesis

Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Before conducting meta-analysis, heterogeneity will be assessed statistically using the standard Chi-square and visual inspection of the meta-analysis output on a forest plot. Because of the possibility of low statistical power if there are few included studies, a significance level of P < 0.1 will be used in order to protect against the possibility of falsely stating that there is no heterogeneity present. Data will also be explored using subgroup analyses based on the different study designs, interventions and populations included in this review. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Effect sizes expressed as odds ratio (OR) and risk ratio (RR) (for categorical data) and standardized mean differences (SMD) (for continuous data) and their 95% confidence intervals will be calculated using DerSimonian and Laird method. Where statistical pooling is not possible the findings will be presented in narrative form.

Conflicts of interest

The authors declare that there is no conflict of interest.

References