Trial Outcomes & Findings for Innovative Tools to Expand HIV Self-Testing (NCT NCT04070287)

Results Overview

Proportion of participants who reported to have self-tested for HIV at 3-month after baseline.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

388 participants

Primary outcome timeframe

3 months following the first encounter

Results posted on

2023-12-21

Participant Flow

Recruitment occurred through a combination of community-based events, social media platforms, and peer referral.

Participant milestones

Participant milestones
Measure	SMART Pack This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers. SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.	Luv Box The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people. Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.	Bili Vibes The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people. Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.	BeterDoc This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people. BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.	IUNGO This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people. IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
Overall Study STARTED	114	86	81	11	96
Overall Study COMPLETED	103	44	75	7	95
Overall Study NOT COMPLETED	11	42	6	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Innovative Tools to Expand HIV Self-Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SMART Pack n=114 Participants This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers. SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.	Luv Box n=86 Participants The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people. Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.	Bili Vibes n=81 Participants The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people. Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.	BeterDoc n=11 Participants This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people. BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.	IUNGO n=96 Participants This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people. IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.	Total n=388 Participants Total of all reporting groups
Age, Continuous	21.0 years STANDARD_DEVIATION 2.8 • n=5 Participants	21.3 years STANDARD_DEVIATION 2.3 • n=7 Participants	21.1 years STANDARD_DEVIATION 1.5 • n=5 Participants	20.7 years STANDARD_DEVIATION 2.1 • n=4 Participants	21.1 years STANDARD_DEVIATION 2.1 • n=21 Participants	21.1 years STANDARD_DEVIATION 2.3 • n=10 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	40 Participants n=7 Participants	30 Participants n=5 Participants	4 Participants n=4 Participants	32 Participants n=21 Participants	160 Participants n=10 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	46 Participants n=7 Participants	51 Participants n=5 Participants	7 Participants n=4 Participants	64 Participants n=21 Participants	228 Participants n=10 Participants
Race/Ethnicity, Customized Yoruba	49 Participants n=5 Participants	57 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	71 Participants n=21 Participants	187 Participants n=10 Participants
Race/Ethnicity, Customized Igbo	30 Participants n=5 Participants	20 Participants n=7 Participants	70 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants	130 Participants n=10 Participants
Race/Ethnicity, Customized Other ethnicity (i.e. Hausa/Fulani)	35 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants	66 Participants n=10 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants

PRIMARY outcome

Timeframe: 3 months following the first encounter

Proportion of participants who reported to have self-tested for HIV at 3-month after baseline.

Outcome measures

Outcome measures
Measure	SMART Pack n=114 Participants This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers. SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.	Luv Box n=86 Participants The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people. Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.	Bili Vibes n=81 Participants The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people. Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.	BeterDoc n=11 Participants This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people. BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.	IUNGO n=96 Participants This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people. IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
Uptake of HIV Self-testing Over the 3 Months Follow-up	19 Participants	7 Participants	24 Participants	4 Participants	22 Participants

SECONDARY outcome

Timeframe: 6-month

Proportion of participants who reported to have self-tested for HIV at 6-month after baseline.

Outcome measures

Outcome measures
Measure	SMART Pack n=114 Participants This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers. SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.	Luv Box n=86 Participants The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people. Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.	Bili Vibes n=81 Participants The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people. Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.	BeterDoc n=11 Participants This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people. BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.	IUNGO n=96 Participants This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people. IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
Uptake of HIV Testing Over the 6 Months Follow-up	98 Participants	32 Participants	64 Participants	4 Participants	91 Participants

SECONDARY outcome

Timeframe: 6-month

Proportion of participants who reported syphilis testing at baseline and 6-month.

Outcome measures

Outcome measures
Measure	SMART Pack n=114 Participants This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers. SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.	Luv Box n=86 Participants The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people. Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.	Bili Vibes n=81 Participants The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people. Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.	BeterDoc n=11 Participants This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people. BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.	IUNGO n=96 Participants This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people. IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
Uptake of Syphilis Testing Baseline	3 Participants	4 Participants	8 Participants	0 Participants	3 Participants
Uptake of Syphilis Testing 6-month	47 Participants	5 Participants	25 Participants	0 Participants	73 Participants

SECONDARY outcome

Timeframe: 6-month

Proportion of participants who reported gonorrhea testing at baseline and 6-month.

Outcome measures

Outcome measures
Measure	SMART Pack n=114 Participants This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers. SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.	Luv Box n=86 Participants The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people. Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.	Bili Vibes n=81 Participants The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people. Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.	BeterDoc n=11 Participants This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people. BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.	IUNGO n=96 Participants This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people. IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
Uptake of Gonorrhea Testing Baseline	5 Participants	5 Participants	3 Participants	0 Participants	5 Participants
Uptake of Gonorrhea Testing 6-month	46 Participants	2 Participants	23 Participants	0 Participants	64 Participants

SECONDARY outcome

Timeframe: 6-month

Proportion of participants who reported hepatitis B testing.

Outcome measures

Outcome measures
Measure	SMART Pack n=114 Participants This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers. SMART Pack: The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.	Luv Box n=86 Participants The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people. Luv Box: The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.	Bili Vibes n=81 Participants The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people. Bili Vibes: The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.	BeterDoc n=11 Participants This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people. BeterDoc: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.	IUNGO n=96 Participants This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people. IUNGO: The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
Uptake of Hepatitis b Testing Baseline	3 Participants	8 Participants	31 Participants	3 Participants	8 Participants
Uptake of Hepatitis b Testing 6-month	46 Participants	6 Participants	45 Participants	2 Participants	75 Participants

SECONDARY outcome

Timeframe: 6-month

Proportion of participants who reported chlamydia testing at baseline and 6-month.