In 2013, over 7.6 million HIV-infected Africans were receiving antiretroviral drugs [
Clinic attendance may be influenced by patient social contexts and interpersonal relations with family members and within communities. Social support systems can help patients overcome structural and financial barriers to accessing care, provide a context for patients to discuss concerns about their diagnosis and treatment, and buffer against community stigma [
Previous studies of TBys have focused largely on ART adherence and HIV outcomes, with mixed results. A prospective cohort study among patients initiating ART at public facilities in South Africa found higher odds of treatment success (defined as viral load < 400 copies/mL, CD4 ≥ 200 cells/mm3) at six months, one year, and two years after ART initiation among patients with TBys [
To our knowledge, only one other study has evaluated effects of a TBy on clinic attendance. A recent RCT of a TBy intervention among 174 patients attending an HIV clinic in Uganda found no difference in clinic attendance during the 28-week follow-up period [
This was a retrospective cohort study of HIV-infected adult patients ≥15 years of age initiating ART between August 1, 2007, and December 23, 2011. The study targeted four Family AIDS Care & Education Services (FACES) supported facilities (PandiPieri, Lumumba, Family Health Options Kenya (FHOK), and Tuungane) in Kisumu County, where the prevalence of HIV (19%) is more than three times the national average for Kenya (6%) [
Prior to ART initiation, the patient is counseled to disclose his/her status to one or two trusted individuals who can support his/her treatment, typically a partner, parent, daughter, sister, brother, friend, or neighbor. The patient brings the TBy to the clinic to participate in the pre-ART adherence counseling process, a series of three counseling and education sessions that cover HIV transmission and risk factors; disease progression and CD4 monitoring; purpose, benefits, and importance of ART medication and adherence; consequences of poor adherence; treatment schedule and reminder systems; and disclosure and positive living. TBys provide ongoing support for positive living and medication adherence. Patients are expected to notify the facility if there is a TBy change.
In Kenya, a patient’s first six-month observation period following ART initiation typically includes a first clinic visit two to four weeks after ART initiation and monthly thereafter. Providers assess health status, adherence, drug regimen tolerance, and toxicity and modify the ARV regimen if needed. Patients are provided with ARV refills to last them until their next clinic visit, which is scheduled that day. A patient may also come to the clinic between scheduled visits as needed. TBys may attend clinic appointments with the patient or may come in the patient’s place to pick up the drugs.
Patient demographic factors, TBy status, and appointment adherence data were extracted from medical encounter forms collected during routine patient care and entered into an open source electronic medical records system database (OpenMRS system version 1.8.3). For the majority of patients (2416/2430), TBy details were extracted from the pre-ART adherence counseling form completed immediately prior to ART initiation. Another 14 patients whose TBy details could not be ascertained from the pre-ART adherence counseling form but who indicated having a TBy at the time of engagement into care were coded as having a TBy. Clinic appointment adherence was defined as completing all scheduled clinic appointments within the first six months on ART. An appointment was deemed completed if the patient was seen on or within three business days after the scheduled return date or had appeared in the clinic prior to the scheduled return date.
The outcome was the proportion of patients who attended all clinic visits within the first six months on ART. TBy was operationalized as dichotomous for primary analyses (1 = having TBy; 0 = having no TBy) and categorical for a secondary analysis that examined clinic attendance by relationship with TBy (1 = having no TBy; 2 = partner is the TBy; 3 = another family member or friend is the TBy). Chi-square tests were performed to assess differences in demographic and clinical characteristics by TBy status. Multivariable Poisson regression with robust standard errors was used to obtain adjusted relative risks. An initial regression model with terms for TBy (dichotomous), gender, and their interaction found a significant difference in male and female response to treatment support at
Use of the program data for research was approved by the Kenya Medical Research Institute (KEMRI) Ethical Review Committee and the Committee on Human Research (11-05348) at the University of California San Francisco. All patient data were stripped of any identifying details and identified only by a unique patient number.
Of 2,430 patients who met inclusion eligibility requirements in this study, 2199 (90.5%) had a TBy (Table
Sample characteristics (
Characteristics | TBy ( |
No TBy ( |
|
---|---|---|---|
Gender | <0.0001 | ||
Male | 770 (94.8) | 42 (5.2) | |
Female | 1429 (88.3) | 189 (11.7) | |
Age (years; enrollment), median (IQR) | 32 (27–39) | 30 (25–35) | <0.0001 |
15–29 | 852 (88.3) | 113 (11.7) | |
30–44 | 1038 (90.7) | 107 (9.3) | |
45+ | 309 (96.6) | 11 (3.4) | |
Education level (enrollment) | 0.05 | ||
None | 57 (98.3) | 1 (1.7) | |
Primary | 1118 (91.2) | 108 (8.8) | |
Secondary | 665 (89.4) | 79 (10.6) | |
College | 164 (93.7) | 11 (6.3) | |
Missing | 195 (85.9) | 32 (14.1) | |
Marital status (enrollment) | <0.0001 | ||
Single | 894 (87.9) | 123 (12.1) | |
Partnered | 1076 (93.1) | 80 (6.9) | |
Missing | 229 (89.1) | 28 (10.9) | |
Children in household (enrollment) | 0.11 | ||
0 | 469 (90.9) | 47 (9.1) | |
1 | 447 (91.4) | 42 (8.6) | |
2 | 457 (88.1) | 62 (12.0) | |
3+ | 563 (92.1) | 48 (7.9) | |
Missing | 263 (89.2) | 32 (10.9) | |
Year ART initiated | <0.0001 | ||
2007 | 31 (79.5) | 8 (20.5) | |
2008 | 242 (80.9) | 57 (19.1) | |
2009 | 513 (91.3) | 49 (8.7) | |
2010 | 749 (92.5) | 61 (7.5) | |
2011 | 664 (92.2) | 56 (7.8) | |
Months from enrollment to ART initiation, median (IQR) | 1 (0–3) | 1 (0–6) | 0.03 |
<1 | 964 (91.7) | 87 (8.3) | |
1-2 | 530 (91.7) | 48 (8.3) | |
2-3 | 131 (86.2) | 21 (13.8) | |
>3 | 574 (88.4) | 75 (11.6) | |
CD4 count (cells/mm3; ART initiation), median (IQR)† | 180 (82–260) | 189 (113–280) | 0.52 |
>350 | 155 (88.6) | 20 (11.4) | |
200–350 | 797 (90.2) | 87 (9.8) | |
<200 | 1207 (91.0) | 119 (9.0) | |
WHO stage (ART initiation)† | 0.03 | ||
1 | 526 (88.9) | 66 (11.2) | |
2 | 697 (88.7) | 89 (11.3) | |
3 | 809 (92.7) | 64 (7.3) | |
4 | 156 (92.9) | 12 (7.1) | |
Clinic site | <0.0001 | ||
Lumumba | 993 (90.8) | 101 (9.2) | |
Tuungane | 73 (97.3) | 2 (2.7) | |
PandiPieri | 1011 (94.9) | 54 (5.1) | |
FHOK | 122 (62.2) | 74 (37.8) | |
Retention during first 6 months on ART | 0.001 | ||
Missed ≥1 visits | 890 (88.2) | 119 (11.8) | |
Missed no visits | 1309 (92.1) | 112 (7.9) |
†There were missing data for the following predictors:
CD4 count: 45 patients; 40 with treatment buddy and 5 without treatment buddy.
WHO stage: 10 patients, all with treatment buddy.
On univariate analysis, patients with a TBy were more likely to achieve consistent appointment adherence (Table
Unadjusted relative risks for factors associated with clinic attendance during the first six months on ART, overall, and by gender.
Predictor | Total ( |
Male ( |
Female ( | ||||||
---|---|---|---|---|---|---|---|---|---|
|
% attended | RR (95% CI) |
|
% attended | RR (95% CI) |
|
% attended | RR (95% CI) | |
Has treatment buddy | |||||||||
Yes | 1309 | 59.5 | 1.23 (1.07–1.41) | 770 | 57.1 | 1.00 (0.76–1.31) | 1429 | 60.8 | 1.31 (1.11–1.53) |
No | 112 | 48.5 | REF | 42 | 57.1 | REF | 189 | 46.6 | REF |
Treatment buddy × gender interaction |
After adjusting for age, marital status, year initiated ART, months from engagement in care to ART initiation, CD4 count, WHO stage, and clinic site, females with a TBy were nearly 30% more likely to meet all scheduled appointments during the appointment follow-up period than those without one (adjusted aRR = 1.28; 95% CI 1.08–1.53; Table
Adjusted relative risks for factors associated with clinic attendance during the first six months on ART, by gender.
Predictor | Male ( |
Female ( | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
|
% attended | aRR | 95% CI |
|
|
% attended | aRR | 95% CI |
|
|
Has treatment buddy | ||||||||||
Yes | 679 | 57.6 | 1.01 | 0.76–1.32 | 0.97 | 1243 | 60.6 | 1.28 | 1.08–1.53 | 0.005 |
No | 37 | 59.5 | REF | 162 | 45.1 | REF | ||||
Age | ||||||||||
15–29 | 173 | 56.7 | REF | 681 | 54.9 | REF | ||||
30–44 | 394 | 56.6 | 0.99 | 0.85–1.15 | 0.90 | 599 | 62.4 | 1.12 | 1.03–1.22 | 0.01 |
45+ | 149 | 61.7 | 1.05 | 0.87–1.25 | 0.62 | 125 | 62.4 | 1.14 | 0.98–1.33 | 0.08 |
Marital status | ||||||||||
Single | 191 | 53.9 | REF | 798 | 54.0 | REF | ||||
Partnered | 525 | 59.1 | 1.02 | 0.89–1.18 | 0.75 | 607 | 65.1 | 1.10 | 1.01–1.20 | 0.04 |
Year ART initiated | ||||||||||
2007 | 6 | 16.7 | 0.20 | 0.03–1.24 | 0.08 | 26 | 42.3 | 0.62 | 0.39–0.99 | 0.04 |
2008 | 78 | 59.0 | 0.83 | 0.66–1.03 | 0.09 | 151 | 54.3 | 0.80 | 0.68–0.94 | 0.007 |
2009 | 163 | 60.7 | 0.97 | 0.82–1.14 | 0.71 | 318 | 53.8 | 0.83 | 0.73–0.94 | 0.003 |
2010 | 245 | 57.1 | 0.90 | 0.77–1.05 | 0.17 | 479 | 61.0 | 0.94 | 0.85–1.04 | 0.24 |
2011 | 224 | 56.7 | REF | 431 | 62.7 | REF | ||||
Months from engagement in care to ART initiation | ||||||||||
<1 | 354 | 52.5 | REF | 581 | 58.5 | REF | ||||
1-2 | 188 | 60.6 | 1.07 | 0.92–1.23 | 0.37 | 315 | 55.9 | 0.92 | 0.82–1.04 | 0.18 |
2-3 | 42 | 61.9 | 1.12 | 0.85–1.48 | 0.40 | 96 | 51.0 | 0.88 | 0.72–1.08 | 0.21 |
>3 | 132 | 65.9 | 1.12 | 0.94–1.32 | 0.20 | 413 | 63.2 | 1.04 | 0.93–1.16 | 0.45 |
CD4 count | ||||||||||
>350 | 38 | 65.8 | 1.09 | 0.84–1.40 | 0.51 | 115 | 56.5 | 0.92 | 0.77–1.09 | 0.32 |
200–350 | 214 | 63.1 | 1.04 | 0.90–1.20 | 0.61 | 565 | 63.4 | 1.05 | 0.95–1.16 | 0.36 |
<200 | 464 | 54.5 | REF | 725 | 55.6 | REF | ||||
WHO stage | ||||||||||
1 | 151 | 67.6 | REF | 365 | 66.0 | REF | ||||
2 | 194 | 61.9 | 0.93 | 0.80–1.09 | 0.36 | 506 | 58.1 | 0.91 | 0.83–1.01 | 0.09 |
3 | 308 | 51.3 | 0.80 | 0.69–0.93 | 0.003 | 454 | 57.1 | 0.91 | 0.81–1.01 | 0.08 |
4 | 62 | 51.6 | 0.74 | 0.57–0.96 | 0.03 | 80 | 40.0 | 0.65 | 0.49–0.85 | 0.002 |
Clinic site | ||||||||||
Lumumba | 345 | 72.5 | REF | 577 | 71.4 | REF | ||||
Tuungane | 22 | 45.5 | 0.58 | 0.36–0.92 | 0.02 | 41 | 31.7 | 0.44 | 0.28–0.69 | 0.0003 |
PandiPieri | 349 | 43.8 | 0.58 | 0.51–0.67 | <0.0001 | 610 | 52.3 | 0.69 | 0.63–0.76 | <0.0001 |
FHOK | na | na | na | na | na | 177 | 46.3 | 0.68 | 0.57–0.81 | <0.0001 |
As with the univariate results, TBy showed no association with clinic attendance in males after adjustment for age, marital status, year initiated ART, months from engagement in care to ART initiation, CD4 count, WHO stage, and clinic site (aRR = 1.01; 95% CI 0.76–1.32; Table
Type of relationship with the TBy differed by patient gender (
Adjusted relative risks for factors associated with clinic attendance during the first six months on ART including relationship to TBy, by gender.
Predictor | Male | Female | ||||||
---|---|---|---|---|---|---|---|---|
|
% attended | RR (95% CI) |
aRR (95% CI) |
|
% attended | RR (95% CI) |
aRR (95% CI) | |
Treatment buddy relationship | ||||||||
Partner/spouse | 250 | 62.4 | 1.18 (1.02–1.36) | 1.05 (0.89–1.24) | 198 | 69.7 | 1.14 (1.03–1.27) | 1.01 (0.90–1.14) |
Other | 303 | 51.8 | REF | REF | 834 | 60.9 | REF | REF |
None | 42 | 57.1 | 1.08 (0.82–1.44) | 1.03 (0.77–1.37) | 189 | 46.6 | 0.76 (0.65–0.90) | 0.75 (0.62–0.90) |
In this study we found better clinic attendance among women with a TBy but not men. Women with a TBy were nearly 30% more likely to have kept all appointments within the first six months on therapy than women without a TBy. Clinic attendance was not significantly different in men with or without a TBy.
For women, these findings have promising implications. Clinically, consistent attendance is essential for timely ART delivery and monitoring for toxicities and treatment failure; preventing ART interruptions is crucial because treatment lapses can result in drug resistance and increased mortality risk [
For men, our finding of no TBy effect on attendance is of special concern because men show a broader pattern of poorer engagement and retention [
Gender differences in social norms and economic standing may also influence how men and women relate to the TBy in other ways. Norms of masculinity that emphasize resilience and self-reliance discourage African men from seeking help from others when needed [
The protocols followed at the clinics included in this study allowed patients to self-select the TBy from among trusted family and friends. Treatment buddies participated in pre-ART preparatory education and counseling sessions with the patient and supported patients with medication reminders. TBys were also encouraged to attend clinic appointments with patients if possible and support patients with pickup of ART refills when necessary and feasible. To our knowledge, only one other study has evaluated a similar patient self-selected TBy intervention on clinic attendance, a recent RCT led by Kunutsor et al. among 174 patients on ART at a hospital in Uganda [
Previous research has shown that patients and providers choose treatment buddies who are confidantes and able to influence health-related decision-making [
Strengths of our study include a large, representative cohort of patients at multiple HIV care settings in Kenya. This is the first study to our knowledge to examine the effectiveness of TBys as an intervention in Kenya and the only large-scale study to examine type of relationship to the TBy among HIV patients in sub-Saharan Africa. A study limitation was that it was based on observational data and may be subject to unmeasured confounding. In particular, because of the self-nominated nature of the TBy intervention at FACES-supported clinics, patients with a TBy may have generally stronger social connections and greater support within their social network than those without a TBy. Thus the TBy may serve as a marker for social capital. Patients initiated on ART without a TBy also reflect an unusual exception to Kenyan guidelines that encourage the selection of a TBy and may therefore differ from the general population of new patients on ART. For example, they may be more disadvantaged or have more clinically advanced illness. Nevertheless, we were able to control for a number of sociodemographic and disease markers to help account for some of these differences. A second limitation of this study was that TBy status could only be ascertained for the 48% of patients initiated on ART during the study period for whom pre-ART adherence counseling data was available in the administrative database. Third, we were not able to directly associate clinic attendance with ARV adherence or clinical outcomes. However, the relationship between clinic attendance and ART adherence and outcomes has been firmly established [
In summary, clinic attendance was higher during the first six months of ART among women with TBys but not men. These results support TBys to help women achieve ART success in resource-poor settings; alternate strategies to bolster TBy benefits are needed for men. Specialized trainings for TBys and caregiver support groups may further enhance the impact of TBys on adherence and health outcomes for all patients on ART.
Parts of data previously were presented at University of Nairobi Conference, Nairobi, January 2013, Second National Biannual HIV/AIDS Research Conference RSA, Nairobi, May 2013, and International Conference on AIDS and STI in Africa (ICASA), Cape Town, December 2013. The findings and conclusions in this paper are those of the authors and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention/Government of Kenya.
No conflict of interests relevant to this paper was reported.
This paper was developed through a Manuscript Writing Workshop organized by the NIH Office of AIDS Research-funded OCTAVE Project. Special thanks are due to Jonathan Fuchs and Matthew Price for their scientific mentorship. Thanks are due to Professor Solomon Mpoke, KEMRI Director, and Dr. Patrick Oyaro, FACES Country Director for professional support. This publication was made possible by support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through Cooperative Agreement no. 1U2GPS001913 from the U.S. Centers for Disease Control and Prevention (CDC), Division of HIV/AIDS (DGHA).