Booklet for healthy lifestyle in people with HIV: a clinical trial

This is a randomized clinical trial at an outpatient clinic in Fortaleza, Ceará, Brazil, with 70 patients in the intervention group and 74 in the control group. People with HIV over 18 years of age, of both sexes, on antiretroviral therapy for more than six months, with a landline or cell phone, and 35 or more points on the Health Literacy Scale were included. Data collection took place in four moments, using the Individual Lifestyle Profile Scale and the Assessment of Antiretroviral Therapy Compliance Questionnaire (Cuestionario para la Evaluación de la Adhesión al Tratamiento Antirretroviral). The control group received routine medical consultation, and the intervention group, in addition to routine consultation, read the booklet in the office, and then took it home. Non-parametric analysis of variance of repeated measures was used for statistics.

Results

Most participants had an unsatisfactory lifestyle at baseline. The booklet improved patients’ lifestyle after two (P<0.001), four (P<0.001) and six months (P<0.001) of intervention, when comparing the different times to baseline and control. There was an improvement in antiretroviral compliance scores in the intervention group when compared to baseline (P<0.001) and control (P<0.001).

Conclusion

The booklet was effective in promoting a healthy lifestyle and improving antiretroviral compliance in people with HIV, therefore, it can complement outpatient consultations.

Brazilian Clinical Trial Registry (ReBEC): RBR-7p6vsr

HIV; Sexually transmitted diseases; Antiretroviral therapy, highly active; Educational technology; Health promotion; Life style; Anti-retroviral agents

Aligned	by	Error	df^*	df^* residue	F^**	p-value^***
Time	Group	Intra	3	426	0.00	1.000
Group: time	Group	Intra	3	426	0.00	1.000
Group	Time	Subjects	1	142	0.00	1.000
Group: time	Time	Intra	3	426	0.00	1.000
Group	Group: time	Subjects	1	142	0.00	1.000
Time	Group: time	Intra	3	426	0.00	1.000
Source of variation
Group (Subjects)			1	142	14.18	< 0.001
Time (Intra)			3	426	37.12	< 0.001
Group: time (Intra)			3	426	10.79	< 0.001

1. Time	EMM^*	SE^**	df ^***	95% ^† CI
Baseline	210	13.2	387	184 - 236
2^nd month	270	13.2	387	244 - 296
3^rd month	322	13.2	387	296 - 348
6^th month	353	13.2	387	327 - 379
1.1 Contrasts	Estimate	SE	df	t^‡	p-value^§
Baseline - 2^nd month	-59.8	14.5	426	-4.12	< 0.001
Baseline - 4^th month	-111.7	14.5	426	-7.70	< 0.001
Baseline - 6^th month	-142.7	14.5	426	-9.84	< 0.001
2^nd month - 4^th month	-51.9	14.5	426	-3.58	0.002
2^nd month - 6^th month	-83.0	14.5	426	-5.72	< 0.001
4^th month - 6^th month	-31.0	14.5	426	-2.14	0.143
2. Group	EMM	SE	df	95% CI
Control	251	14.2	142	223 - 279
Intervention	326	14.2	142	298 - 354
2.1 Contrasts	Estimate	SE	df	t	p-value
Control - Intervention	-75.7	20.1	142	-3.77	< 0.001
3. Pairs of groups and times	Estimate	SE	df	t	p-value
Control – Intervention (Baseline - 2^nd month)	107.7	29.8	426	3.62	< 0.001
Control – Intervention (Baseline - 4^th month)	129.8	29.8	426	4.36	< 0.001
Control – Intervention (Baseline - 6^th month)	158.4	29.8	426	5.32	< 0.001
Control – Intervention (2^nd month - 4^th month)	22.1	29.8	426	0.74	0.459
Control – Intervention (2^nd month - 6^th month)	50.7	29.8	426	1.70	0.089
Control – Intervention (4^th month - 6^th month)	28.6	29.8	426	0.96	0.337

Intergroup comparison	Rank average		W^*	p-value
Intergroup comparison	Control	Intervention	W^*	p-value
Baseline	74.75	70.12	2756.5	0.506
6 months	59.67	86.06	1640.5	<0.001
Intra-group comparison	Baseline	6 months	V	p-value
Control	70.87	78.13	390	0.151
Intervention	54.96	86.04	226	<0.001

Escola Paulista de Enfermagem, Universidade Federal de São Paulo R. Napoleão de Barros, 754, 04024-002 São Paulo - SP/Brasil, Tel./Fax: (55 11) 5576 4430 - São Paulo - SP - Brazil
E-mail: actapaulista@unifesp.br

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[1] Corresponding author. Gilmara Holanda da Cunha. E-mail:gilmaraholandaufc@yahoo.com.br