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Antiretroviral Adherence in Rural Zambia: The First Year of Treatment Availability

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  • 1 International Neurologic and Psychiatric Epidemiology Program, Michigan State University, East Lansing, Michigan; Chikankata Health Services, Mazabuka, Zambia; Department of Paediatrics and Child Health, University of Zambia, Lusaka, Zambia; Michigan State University College of Osteopathic Medicine, East Lansing, Michigan; Michigan State University College of Human Medicine, East Lansing, Michigan; Monze Mission Hospital, Monze, Zambia; Provincial Health Office, Eastern Province, Chipata, Zambia

We conducted a retrospective chart review of antiretroviral therapy (ART) clinic patients treated during the first 12 months after clinics opened in rural Zambia and assessed adherence based on clinic attendance, patient report, and staff assessment. We identified 255 eligible patients (mean age, 39.7 years; 44.3% male; 56.5% married; and 45.5% with only primary school education). Twenty percent had partners known to be HIV positive. Twenty percent were widowed. Thirty-seven percent had disclosed their HIV status to their spouse. Disclosure was less likely among women (27.5% versus 49.6%, P = 0.0005); 36.5% had “clinic buddies” to provide adherence support. Adherence rates were good for 59.2%. Disclosure of HIV status to ones’ spouse (P = 0.047), knowing spouses’ HIV status (P = 0.02), and having a clinic buddy (P = 0.01) were associated with good adherence. Social support is a key patient-level resource impacting ART adherence in rural Zambia. Limited spousal disclosure affects women more than men. Clinic buddies are associated with better adherence.

INTRODUCTION

In response to the World Health Organization’s (WHO) “3 by 5” initiative and expanded efforts toward universal access by 2010, antiretroviral therapy (ART) is becoming more widely available in sub-Saharan Africa, where 65% of people living with HIV/AIDS (PLWA) reside. 1,2 Initial concerns that ART delivery with inadequate planning and poor politics will result in “antiretroviral anarchy”3 were countered by several studies showing that PLWA in Africa can maintain adherence rates that meet or exceed average ART adherence rates in the United States.47 Ample evidence has shown that patients on ART in Africa can benefit substantially from these life-sustaining treatments. 7,8 These adherence studies, however, were largely conducted in urban research settings with select populations of patients,8 in care settings replete with resources for non-medicinal inducements to support clinic adherence (e.g. food supplements), 6,9 or among patients receiving home-based care.7 Few studies have been conducted on an unselect population of patients receiving antiretroviral drugs in a routine (routine refers to the usual circumstances of ART clinic care provision without additional resources for encouraging clinic attendance or extensive home-based care services) care setting or rural populations. Inadequate clinical and biological follow-up in Gabon, the Ivory Coast, and Uganda have been linked to high rates of drug resistence. 10 Evaluating adherence rates in routine care and assessing modifiable factors associated with good adherence is critical for ART program planning in Africa.

A meta-analysis of Africa-based adherence studies identified important adherence factors to be cost, disclosure/stigma fears, alcohol abuse, and ART regimen complexity. 11 Out-of-pocket payment for antiretroviral drugs represents the most obvious barrier to adherence in resource-poor settings, even when medications are substantially subsidized. 12 This has been recognized as an access issue rather than a true adherence issue. 13 Active alcohol or substance abuse has been identified as a relative contraindication for providing ART. 14 Simplified regimens with fixed-dose combinations antiretroviral drugs are now available at relatively affordable prices and usually comprise the ART provided in “routine” care.

Patient-specific factors related to ART adherence have been examined in Africa. Socioeconomic factors (poverty, level of education) have not been found to be predictive of adherence, but psychosocial factors such as depression have been predictive of adherence in prior studies conducted mostly in urban and peri-urban populations. 15 Little is known regarding factors impacting adherence in routine care settings in rural African ART clinics, although ~65% of the population of African countries with high HIV prevalence rates reside in rural regions. 16

Approximately 16% of Zambia’s population 15–45 years of age is HIV positive. 17 Operational research to assess strategies to maximize adherence has been identified as a research priority in Zambia. 18 Before initiation of a prospective cohort study assessing ART adherence among patients attending three rural ART clinics in Zambia’s Southern Province, the Rural ART Adherence in Zambia (RAAZ) study team conducted a retrospective chart review to assess ART adherence in these clinics from the time of each clinic’ opening.

MATERIALS AND METHODS

Study sites.

Study sites included three rural ART clinics (Chikankata, Monze, and Nakambala) located in Zambia’s Southern Province. Each site received funding from routine sources for medications (e.g., the President’s Emergency Fund for AIDS Relief, Zambian government, the Global Fund), but without additional resources beyond those provided to most ART clinics in the region. Care at the clinics was provided by a combination of medical officer, clinical officer, and nurses. No food supplements or transport were provided to clinic attendees during the observation period. Chikankata and Monze are faith-based organizations that receive governmental support. Nakambala is an employer-sponsored healthcare service provided by one of Zambia’s largest private employers. All sites provide antiretroviral drugs and associated laboratory tests free of charge. During the observation period (May 2005 to April 2006), a fixed-dose combination pill containing stavudine, lamivudine, and nevirapine was the mainstay of treatment at all sites without recourse to second-line agents.

After reviewing record keeping and data ascertainment practices within each of the three ART clinics, we developed a sampling method and standardized chart abstraction tool.

Sampling.

All sites used identical forms for ART clinic enrollment and adherence assessments (see appendices). Each site assigned patient ART clinic file numbers in consecutive order of registration and maintained registry information in a central book as well as storing clinic files on site. For two clinics, which had opened some months before the retrospective study, a random number generator was used to pull a 10% random sample of registered ART clinic patients’ files for abstraction. For the third clinic (Nakambala), which had been open for a shorter time and serves a smaller catchment area, all eligible charts were abstracted.

Inclusion criteria included the following: the file could be located; the patient was 18 years or older; the patient had been started on antiretroviral drugs; the patient had not been transferred to another ART clinic, because patients take their files with them on transfer.

Random numbers were generated until a 10% sample of registered patients had been identified at Monze and Chikankata. All files at Nakambala were reviewed. Exclusion circumstances were noted based on sampling (at Chikankata and Monze) or the consecutive numbering system (at Nakambala).

No personally identifiable data beyond the study subjects’ ART clinic file number was recorded. This study was approved by the University of Zambia’s Research Ethics Committee (UNZA REC) and Michigan State University’s Biomedical Institutional Review Board (MSU BIRB).

Data abstraction and quality control.

A trained data abstractor used the random numbers generated to select patients for abstraction and recorded reasons for excluded patients. Clinic staff were alerted when files could not be located and assisted with attempts to locate these. Data were abstracted from eligible patients’ files. To determine data acquisition quality, a random 10% sample of the abstracted files was re-abstracted by a second trained person blinded to the initial abstraction and κ scores were reviewed for each abstracted variable.

Key variables.

Abstracted data included clinic site of care, demographic and social characteristics, medical data and outcomes for adherence and/or death. Clinic follow-up forms included a visual analog scale (to be completed by the patient) and two questions regarding pills missed in the preceding 1 and 3 days. The visual analog scale has been validated and is associated with multiple biological parameters confirming adherence. 19 Adherence was categorized as follows: 1) good, patient attended all scheduled ART clinic visits with no lapse in drug collection and no documentation indicating adherence problems; 2) poor, ART clinic staff documented significant adherence concerns or the patient was > 1 week late in attending a scheduled ART clinic visit with an associated lapse in antiretroviral drug availability; 3) lost, patient failed to return for scheduled follow-up after starting antiretroviral medications (because active tracing of patients was very limited during the observation period, the outcome was otherwise unknown for most patients lost to follow-up); 4) died, patient was known to have died within 30 days of starting antiretro viral medications.

Clinic charting habits were directly observed, and staff were interviewed to assess the most appropriate handling of “not documented” variables. For example, staff universally reported that they carefully documented disclosures and clinic buddies, because these were important for their purposes in terms of tracking and proxy drug collection. However, when there were no disclosures, healthcare workers were very inconsistent in their documentation of “no disclosures.” Therefore, when no disclosures or buddies were documented, this was coded as representing no disclosures and no buddies.

Data analysis.

Data were originally recorded on paper and entered into Excel for importation into EPI INFO. Descriptive data for the overall study population is reported. For known deaths, time from ART initiation to death and cause of death were reviewed. For patients lost to follow-up, time from ART initiation to last clinic visit was reviewed. χ2 and t tests were completed to assess for any association between demographic, medical and social support variables and “good” adherence. If the variable of interest was not documented for age, sex, education, marital status, household composition, CD4 count, or WHO Clinical Case Definition staging (WHO CCD), that subject was dropped from that analysis. Receipt of home-based care services, clinical symptoms, prior medical histories of tuberculosis (TB) and sexually transmitted diseases, possessing an ART clinic buddy, and HIV status disclosures were assumed absent unless documented as being present. We repeated this analysis stratifying by site of care to assess homogeneity of the sample and robustness of the findings. Data for the abstraction quality assurance check were imported from Excel into MedCalc for κ calculation.

RESULTS

A total of 484 files were selected for review to identify 255 charts eligible for abstraction. Sampling data are provided in Table 1. Lost files comprised 12.1% of the sample with most of the lost files (67.8%) occurring at a single clinic. The most common reason for exclusion was that the patient had not yet begun antiretroviral drugs. Inter-rater agreement on the abstraction quality assessment was > 0.8 for all non-linear variables (see Appendix 2 for details).

Table 2 provides descriptive details for the sample. The median number of visits during the observation period was 5 (IQR, 4–7). Mean age was 39.7 years, 44.3% of study subjects were male, and less than one half had secondary school education or higher. Over one half were married, with almost 20% widowed. One in five knew their partner to be HIV positive. Just over one third of subjects reported disclosure of their HIV status to their spouse. The remainder had only disclosed to family members or friends. A third of the files provided no documentation regarding disclosures. Only 7.5% of study subjects were receiving home-based care services, and 36.5% had an ART clinic buddy who accompanied them for one or more visits. CD4 counts were available for 53% (N = 136) of subjects, with a mean CD4 of 138/mm3 before ART initiation. A quarter of the sample had a history of TB, and 5.5% were on TB medication at the time antiretroviral medications were initiated. Adherence rates were good for 59.2% of subjects, 13.7% were lost-to-follow-up, and 5.9% were known to have died. Most of these deaths occurred within 30 days of starting antiretroviral drugs and 60% of losses to follow-up occurred after the first month antiretroviral drugs were initiated (i.e., subjects never returned to clinic after the antiretroviral medications were dispensed the first time).

Table 3 shows the association between patient characteristics and good adherence. Adherence rates did not differ significantly across the three sites (P = 0.13). No medical parameters captured in this retrospective chart review were associated with good adherence. Age, sex, education, marital status, household composition, and partner’s HIV status were not associated with good adherence, but knowing the status of one’s partner (P = 0.02), disclosure of one’s HIV status to one’s spouse (P = 0.047), and having an ART clinic buddy (P = 0.01) were all associated with good adherence.

The analysis in Table 3 stratified by site showed only one statistically significant difference between individual sites and their pooled data. At Nakambala, a larger number of children in the household was associated with poorer adherence rates (P = 0.04), and when stratified further by sx, this finding was only true for women attending the Nakambala clinic and not men (P = 0.003). (Nakambala also had a higher number of children per household [4.3] compared with Chikankata [3.0] and Monze [3.1]; P = 0.02. This is likely related to the paid employment status of all Nakambala households.)

When the results were disseminated locally, ART clinic staff suggested that disclosure to one’s spouse is much more common among men than women. We therefore completed a post hoc analysis of disclosure by sex and found this observation to be correct—only 27.5% of women compared with 49.6% of men reported having disclosed their status to their spouse (P = 0.0005).

DISCUSSION

Strengths and limitations.

Several strengths and limitations of this study deserve mention. To our knowledge, this is the first report of ART adherence in a rural region of sub-Saharan Africa from a representative sample of patients under routine care parameters. The study assessed adherence outcomes through a combination of subjective and objective measures—objective being clinic attendance and subjective being patient self-report and staff assessment among those attending clinic. During the observation period, antiretroviral medications were always in stock at the three study sites, and antiretroviral drugs and ART clinic care were supplied free of charge removing direct cost as a barrier to adherence.

The Chikankata and Monze population consists almost entirely of a single ethnic group (Tonga) and therefore the findings may not be generalizable to Zambia or the surrounding region. Given the retrospective chart review nature of this study, variables for analysis were limited to those routinely documented in the ART clinic files. Assumptions had to be made about the meaning of “not documented” for some variables. The checklist approach developed for the ART clinic enrollment, adherence, and follow-up forms used at all study sites (see Appendices) assisted substantially in allowing variables to be abstracted consistently across sites. However, 12% of the files randomly sampled by clinic registration numbers were lost and could not be located. Disclosure data were not documented in almost one third of the files. Furthermore, no data were available regarding indirect costs of adherence such as time and resources needed to travel to the clinic. No socioeconomic data aside from level of education were available. Our adherence assessment relied on records of drug collection and patient self-reported adherence measures. More objective measures such as pill counts were not incorporated into routine care in these clinics. The adherence measure used in this study could not be correlated with more objective methods such as virologic outcomes and nevirapine plasma levels. Patients lost to follow-up may represent treatment defaulters or deaths.

Adherence determinants within individuals may vary with time. Nachega and others 20 suggested that long-term adherence is largely determined by how successfully patients can shift psychologically from an early obsession with survival to a stage of empowered living sustained through social support. Our study assessed individual adherence during the first 12 months these clinics were open and therefore assesses adherence in patients newly initiated on antiretroviral drugs in a community where treatment was not previously available. The median observation period was too brief for meaningful tracking of treatment outcomes, but within in this rural population with antiretroviral drugs newly available, high rates of treatment abandonment and a significant number of deaths were evident in this short observation period, offering important insights into what occurred when ART clinics initially opened. Presumably as clinics become established and antiretroviral drugs are initiated earlier in the course of HIV disease, this will change, but there is value to establishing the initial dynamic. Re-assessing adherence among patients attending these clinics in 1–2 years may enhance our understanding not only of individual factors affecting adherence but of local cultural factors impacted by the availability of treatment.

Study in context.

Findings from this quantitative study conducted among people attending ART clinics in rural Zambia are remarkably congruent with previously published qualitative and quantitative research undertaken in other settings. Reports at 19 months of follow-up from the urban Zambian scale up of ART care found 70% of ART recipients to be alive and attending ART clinics, with most deaths occurring within 90 days of starting antiretroviral drugs. 21 Other studies have found early mortality among ART recipients in Africa to be similarly high.8 This likely reflects the advanced stage of disease at the time of treatment when treatment is initially made available to a population. In the urban Zambian study population and our rural population, age, sex, CD4 count at entry, and TB co-infection were all unrelated to adherence. Regarding HIV disclosures, studies in Ethiopia also found that only one third of people disclose their HIV-positive status to their partner. 22

In South Africa, disclosure of one’s HIV status is associated with an improved ability to access ART services. 23 Our work shows that disclosure is also associated with better adherence among those who access ART care. Qualitative research in the Soweto region of South Africa has suggested that a treatment supporter (i.e. clinic buddy) is a valuable aid in promoting adherence and that failure to disclose one’s HIV status to one’s sexual partner because of fear of stigma is associated with poor adherence. 20 Our findings certainly support this perspective. Disclosure to one’s sexual partner has been recognized as a double-edged sword 2325—disclosure has the potential to yield much-needed social support. Alternatively, it may result in stigmatization, discrimination, or abandonment. As has been suggested by qualitative studies, we found patients were more likely to disclose their HIV status to family and friends than to their partner. This was especially true for women. All patients who reported spousal disclosures had also informed family or friends.

Preferences to disclose to family members over ones’ spouse may be because of the perceived stability of the family relationships relative to marital/sexual relationships. In our study, disclosure to ones’ spouse may be a proxy for a stable, long-standing relationship. However, the sex differences in disclosure behavior suggest that social norms and expectations related to sex inequities and vulnerability may also play a substantive role. 26 Recent Human Rights Watch publications have documented concerns that violence and sex-based discrimination impair Zambian women’s ability to access and adhere to AIDS treatments. 27 Sex-specific barriers to ART adherence were also evident for households with a large number of children. Women in such households may have too many domestic responsibilities to effectively seek care and adhere to medications. Programs aimed at providing childcare during clinic visits might alleviate this problem.

From a programmatic perspective, the 13% loss to follow-up, which occurred primarily after patients received their first month’s supply of antiretroviral drugs, is extremely concerning. However, simply tracking defaulters may offer little in terms of improved adherence. Stringer and others 21 determined that 19 home visits would have to be made to result in a single return clinic visit because most defaulters in their study had given invalid addresses or moved. (Anecdotally, similar false addresses have been reported by ART clinic staff attempting to trace patients lost from follow-up in our ongoing prospective study.) Resources for adherence improvement might be better directed toward providing inducements for patients to return to clinic (e.g. food supplements), although it is important to recognize that such inducements may result in higher clinic attendance without an associated improvement in ART adherence. Further research needs to be conducted incorporating rigorous tracing to assure that the early defaulters have not in fact died. Qualitative evaluations are also needed among those who default early to determine what leads individuals who attended three to five “preparatory” ART clinic visits to opt never to return after receiving their first supply of antiretroviral medications.

Directly observed therapy (DOTS) has been proposed as one means of enhancing adherence to ART, but there is some debate as to whether DOTS may contribute to stigma because the method of observation and observer selection can result in forced disclosure. 28,29 The use of “clinic buddies” as treatment supporters has been identified as one means of instituting some social and logistical support for people on antiretroviral medications. 5,20 Our study found that the “buddy” system offers some of the benefits of DOTS but is relatively cost free and with limited risks of forced disclosure because the ART clinic attendee selects their own buddy.

This study suggests that psychosocial factors surrounding stigma fears and resultant concealment of HIV status are key determinants of adherence among rural Zambians receiving antiretroviral drugs. Negative social factors seem to impact women more than men. Programs aimed at decreasing AIDS-related stigma, especially stigma aimed at women, are needed to improve adherence, optimize clinical outcomes, and avoid the development of drug resistance in the region.

Spousal disclosure and clinic buddy may simply be proxy variables for pre-existing social supports and networks and as such may not be individually modifiable. However, even if gradations of social supports remain static, changes in the social milieu that make HIV less stigmatized could increase spousal disclosure rates and clinic buddy use for all strata of social supports and therefore potentially increase adherence. Repeat measures of HIV-associated stigma and ART adherence may further elucidate this important social phenomena.

Table 1

Sampling data (N = 484)

Table 1
Table 2

Descriptive data (N = 255)

Table 2
Table 3

Association between patient characteristics and good adherence*

Table 3

*

Address correspondence to Gretchen L. Birbeck, 324 West Fee Hall, East Lansing, MI 48824. E-mail: Gretchen.Birbeck@ht.msu.edu

Note: The appendix “Inter-rater agreement on abstraction quality assessment” appears online at www.ajtmh.org.

Authors’ addresses: Gretchen L. Birbeck, Michigan State University, PO Box 670008, 324 West Fee Hall, East Lansing, MI 48824, Tel: 517-884-0277 or 517-884-0275, E-mail: birbeck@msu.edu. Elwyn Chomba, UNZA Department of Pediatrics & Child Health, PO Box 31210, Lusaka, Zambia, Tel: 260-1-254655, Fax: 260-1-291607, E-mail: echomba@zamnet.zm. Michelle Kvalsund, 324 West Fee Hall, East Lansing, MI 48824, Tel: 517-884-0276, Fax: 517-884-0275, E-mail: powellmi@msu.edu. Richard Bradbury, Chikankata Health Services, Private Bag S2, Mazabuka, Zambia, Cell: 260-097-703199, Fax: 260-32-35765, E-mail: rbradbury@chikankata.org.zm. Charles Mang’ombe, Senior Clinical Officer, Chikankata Health Services, Private Bag S2, Mazabuka, Zambia, Cell: 260-097-851053, Fax: 260-32-35765, E-mail: cmangombe@chikankata.org.zm. Kennedy Malama, PO Box 660029, Monze, Zambia, Tel: 260-32-50142, Fax: 260-32-50804, E-mail: monzehos@zamtel.zm. Trevor Kaile, Chikankata Health Services, Chief Medical Officer, Private Bag S2, Mazabuka, Zambia, Cell: 260-095-752291, Fax: 260-32-35765, E-mail: tkaile89@yahoo.co.uk. Peter A. Byers, Michigan State University College of Human Medicine, 324 West Fee Hall, East Lansing, MI 48824, Tel: 517-884-0276, Fax: 517-884-0275, E-mail: byerspet@msu.edu. Natalie Organek, E-mail: Natalie.Organek@hc.msu.edu.

Acknowledgments: RAAZ Study Team: Principal Investigator—Gretchen L. Birbeck, Michigan State University, Associate Professor and Director, International Neurologic and Psychiatric Epidemiology Program, East Lansing, MI, and Chikankata Health Services, Mazabuka, Zambia; Michelle P. Kvalsund, Michigan State University, College Osteopathic Medicine and Department of Epidemiology, Senior Research Assistant and Trainer; Peter Byers, Michigan State University, College of Human Medicine, Trainer; Jamey Hardesty, Michigan State University, Department of Microbiology, Research Assistant; Natalie Organek, Michigan State University, College of Osteopathic Medicine. External Advisor—Elwyn Chomba, University of Zambia, Consultant, Department of Pediatric and Child Health, Lusaka, Zambia. Chikankata Health Services—Richard Bradbury, Administrator; Trevor Kaile, Chief Medical Officer; Charles Mang’ombe, Senior Clinical Officer and Program Coordinator; Gamaliel Misago, Senior Medical Officer; Fridah Kabwenda, Research Assistant and Assistant Coordinator; Charles Mabeta, Research Assistant; Lutangu Mulolo, Research Assistant. Monze Mission Hospital—Kennedy Malama, Chief Medical Officer; Lillian Simweene, Research Assistant; Stenga Muzabani, Research Assistant. Nakambala Clinic—Roy Silavwe, Research Assistant; Namakau Lisulo, Research Nurse; Margaret Sampa, Research Assistant. N. Organek assisted in technical support, data acquisition and provided a critical review of the manuscript.

Financial support: Funding for this work was provided by the Doris Duke Charitable Foundation through their 2005 Operations Research for AIDS Care and Treatment in Africa (ORACTA) program. The funders did not participate in or direct the design of this work or development of this manuscript.

Dislosure: None of the authors had any conflicts of interest.

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