Improving early childhood care and development, HIV-testing, treatment and support, and nutrition in Mokhotlong, Lesotho: study protocol for a cluster randomized controlled trial

Table 2 Schedule of enrollment, interventions, and assessments following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure

	Allocation	Enrollment	Post allocation					Close-out
			Weeks 1–8	Weeks 6–18	Weeks 16–24	Weeks 21–25	Weeks 68–76
Time point	0		Baseline	Group intervention	Post-intervention follow-up	Community health outreach day	12-month follow-up	18 months post intervention
Enrollment:		X	X
Eligibility screen		X
Informed consent			X	X	X		X
Allocation	X
Interventions:
Intervention condition				X		X
Control condition						X
Assessments:
Primary outcomes:
HIV-testing rate			X		X		X
Child language			X		X		X
Child attention			X		X		X
Secondary outcomes:			X		X		X
Child cognitive development			X		X		X
Child growth			X		X		X
HIV treatment uptake			X		X		X
HIV treatment adherence			X		X		X
Child emotional and behavioral functioning			X		X		X
Child executive functioning			X		X		X
Parental discipline			X		X		X
Parenting stress			X		X		X
Parental sensitivity			X		X		X
Caregiver mental health			X		X		X
Alcohol use			X		X		X
Mediators:			X		X		X
Positive parenting			X		X		X
Stimulation of child at home and preschool			X		X		X
Moderators:
Socioeconomic status			X		X		X
Family structure/caregiver relationship			X		X		X
Caregiver mental health			X		X		X
Child gender		X
Quality/fidelity of intervention received			X		X		X

ISSN: 1745-6215